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Trial record 56 of 565 for:    applied AND irritation

Atralin Gel for the Treatment of Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01125930
Recruitment Status : Terminated (Due to slow recruitment and sponsor request study ended early)
First Posted : May 19, 2010
Results First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Lisa E. Maier, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rosacea
Interventions Drug: vehicle gel
Drug: Atralin gel
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Period Title: Overall Study
Started 22 46
Completed 21 36
Not Completed 1 10
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             1             6
Protocol Violation             0             1
Lost to Follow-up             0             2
Arm/Group Title Vehicle Gel Atralin Gel Total
Hide Arm/Group Description Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study. Total of all reporting groups
Overall Number of Baseline Participants 22 46 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 46 participants 68 participants
55.00  (11.24) 56.09  (11.58) 55.74  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 46 participants 68 participants
Female
15
  68.2%
39
  84.8%
54
  79.4%
Male
7
  31.8%
7
  15.2%
14
  20.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 46 participants 68 participants
Caucasian, European descent 22 43 65
Caucasian, non-European descent 0 2 2
Middle Eastern 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 46 participants 68 participants
22 46 68
1.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
Hide Description Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 0 0
Mild Erythema 12 22
Moderate Erythema 9 13
Marked Erythema 0 1
Deep Erythema 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
2.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
Hide Description Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 1 0
Mild 10 22
Moderate 10 13
Severe 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
3.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
Hide Description Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 21 31
Mild 0 5
Moderate 0 0
Severe 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
4.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
Hide Description Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 13 16
Slight Flaking 7 12
Moderate Flaking/Scaling 1 8
Marked Scaling/Fissuring 0 0
Severe Scaling/Fissuring 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
5.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Hide Description Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
Yes 19 33
No 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Hide Description Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 15 28
Mild 6 7
Moderate 0 1
Severe 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
7.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Hide Description Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
None 17 27
Mild 4 8
Moderate 0 1
Severe 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
8.Primary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
Hide Description Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
Strongly like product 2 8
Like product 7 7
Neutral 9 16
Dislike product 3 5
Strongly dislike product 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
9.Secondary Outcome
Title Quality of Life
Hide Description The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame 2, 6, 12, 18, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18 Vehicle Gel at Week 24 Atralin Gel at Week 24
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36 21 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.62  (3.01) 2.28  (2.31) 2.19  (2.36) 2.44  (2.21) 1.95  (2.25) 2.03  (1.92) 1.52  (1.63) 2.14  (2.26) 1.43  (1.60) 2.14  (2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 24, Atralin Gel at Week 24
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
10.Secondary Outcome
Title Photodamage
Hide Description Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36
Measure Type: Number
Unit of Measure: participants
Score of 0, No Photo Damage 0 0
Score of 1, Mild Photo Damage, < score of 2 3 1
Score of 2, Mild Photo Damage 5 11
Score of 3, Mild Photo Damage, > score of 2 4 12
Score of 4, Moderate Photo Damage 5 9
Score of 5, Moderate Photo Damage, > score of 4 2 2
Score of 6, Moderate/Severe Photo Damage 2 1
Score of 7, Severe Photo Damage, < score of 8 0 0
Score of 8, Severe Photo Damage 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
11.Secondary Outcome
Title Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Hide Description Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
Time Frame 2, 6, 12, 18 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18 Vehicle Gel at Week 24 Atralin Gel at Week 24
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 18 32 19 31 18 32 19 32 19 34
Mild 3 4 2 4 3 4 2 4 1 2
Moderate 0 0 0 1 0 0 0 0 1 0
Severe 0 0 0 0 0 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 24, Atralin Gel at Week 24
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
12.Secondary Outcome
Title Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Hide Description Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
Time Frame 2, 6, 12, 18 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18 Vehicle Gel at Week 24 Atralin Gel at Week 24
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 21 34 21 34 21 34 21 34 21 35
Mild 0 2 0 2 0 2 0 2 0 1
Moderate 0 0 0 0 0 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 24, Atralin Gel at Week 24
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
13.Secondary Outcome
Title Signs of Other Rosacea Subtypes: Papulopustular
Hide Description Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
Time Frame 2, 6, 12, 18, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18 Vehicle Gel at Week 24 Atralin Gel at Week 24
Hide Arm/Group Description:
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36 21 36
Mean (Standard Deviation)
Unit of Measure: inflammatory papule
0.19  (0.51) 0.25  (0.73) 0.14  (0.48) 0.28  (0.66) 0.43  (0.87) 0.50  (1.59) 0.48  (0.87) 0.64  (1.59) 0.38  (0.67) 1.03  (2.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 24, Atralin Gel at Week 24
Comments Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values to address non-normality of data.
14.Secondary Outcome
Title Molecular Markers of Inflammation
Hide Description These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population that completed baseline and Week 24 biopsies
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: fold change
TAC1 Fold Change Score 2.91  (1.94) 0.87  (0.90)
CXCR4 Fold Change Score 1.39  (1.18) 1.88  (1.81)
CXCL12 Fold Change Score 1.10  (0.80) 1.20  (0.59)
TNFa Fold Change Score 1.24  (0.84) 1.17  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of TAC1 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of CXCR4 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of CXCL12 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of TNFa at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
15.Secondary Outcome
Title Molecular Evidence of Photodamage
Hide Description These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population that completed baseline and week 24 biopsies
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: fold change
COL-1 Fold Change Score 1.50  (1.09) 1.17  (0.65)
COL-3 Fold Change Score 1.39  (0.77) 1.04  (0.63)
MMP1 Fold Change Score 1.44  (1.28) 0.83  (0.60)
MMP3 Fold Change Score 2.87  (3.58) 0.69  (0.64)
MMP9 Fold Change Score 2.53  (4.16) 1.67  (1.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of COL-1 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of COL-3 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of MMP-1 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of MMP-3 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vehicle Gel, Atralin Gel
Comments Group comparisons of MMP-9 at Week 24 visit were made using fold change data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
16.Secondary Outcome
Title Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Hide Description Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 0 1 1 1 1 0 1 0
Mild Erythema 11 18 11 16 12 20 11 23
Moderate Erythema 10 17 9 18 8 14 9 11
Marked Erythema 0 0 0 1 0 2 0 2
Deep Erythema 0 0 0 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
17.Secondary Outcome
Title Severity of Erythematotelangiectatic Signs: Telangiectasia
Hide Description Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 0 0 1 0 1 0 1 0
Mild 7 17 9 19 10 20 10 21
Moderate 14 18 11 16 10 15 10 14
Severe 0 1 0 1 0 1 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
18.Secondary Outcome
Title Severity of Erythematotelangiectatic Signs: Facial Edema
Hide Description Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 21 33 21 33 21 31 21 32
Mild 0 2 0 3 0 5 0 4
Moderate 0 1 0 0 0 0 0 0
Severe 0 0 0 0 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
19.Secondary Outcome
Title Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Hide Description Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 8 13 13 13 12 10 13 14
Slight Flaking 12 17 7 19 8 18 6 14
Moderate Flaking/Scaling 1 5 1 3 1 7 2 8
Marked Scaling/Fissuring 0 1 0 1 0 0 0 0
Severe Scaling/Fissuring 0 0 0 0 0 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values
20.Secondary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Hide Description Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
Yes 17 34 18 32 18 32 18 34
No 4 2 3 4 3 4 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Secondary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Hide Description Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 16 26 17 24 16 23 16 24
Mild 3 7 3 10 5 8 5 10
Moderate 2 2 1 1 0 5 0 2
Severe 0 1 0 1 0 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
22.Secondary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Hide Description Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 21 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
None 17 25 19 24 19 26 19 26
Mild 4 10 2 10 2 9 2 8
Moderate 0 0 0 2 0 0 0 2
Severe 0 1 0 0 0 1 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
23.Secondary Outcome
Title Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Hide Description Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 20 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
Strongly like product 0 3 2 3 2 5 1 7
Like product 3 8 4 9 4 11 5 9
Neutral 17 23 13 20 12 18 13 18
Dislike product 0 2 2 4 2 2 2 2
Strongly dislike product 0 0 0 0 1 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
24.Secondary Outcome
Title Skin Irritation Assessed by Facial Stinging Upon Product Application
Hide Description [Not Specified]
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 20 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
No stinging 17 24 20 20 20 25 19 25
A little stinging 3 12 1 15 1 9 2 11
A lot of stinging 0 0 0 1 0 2 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
25.Secondary Outcome
Title Skin Irritation Assessed by Facial Itching Upon Product Application
Hide Description [Not Specified]
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 20 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
No itching 18 31 21 27 21 30 21 31
A little itching 2 5 0 7 0 5 0 4
A lot of itching 0 0 0 2 0 1 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
26.Secondary Outcome
Title Skin Irritation Assessed by Facial Burning Upon Product Application
Hide Description [Not Specified]
Time Frame 2, 6, 12, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.
Arm/Group Title Vehicle Gel at Week 2 Atralin Gel at Week 2 Vehicle Gel at Week 6 Atralin Gel at Week 6 Vehicle Gel at Week 12 Atralin Gel at Week 12 Vehicle Gel at Week 18 Atralin Gel at Week 18
Hide Arm/Group Description:
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Number of Participants Analyzed 20 36 21 36 21 36 21 36
Measure Type: Number
Unit of Measure: participants
No burning 17 28 19 26 20 24 19 29
A little burning 3 7 2 10 1 10 2 6
A lot of burning 0 1 0 0 0 2 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 2, Atralin Gel at Week 2
Comments Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 6, Atralin Gel at Week 6
Comments Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 12, Atralin Gel at Week 12
Comments Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vehicle Gel at Week 18, Atralin Gel at Week 18
Comments Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank sum test with exact p-values.
Time Frame Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Gel Atralin Gel
Hide Arm/Group Description Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
All-Cause Mortality
Vehicle Gel Atralin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Gel Atralin Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      1/46 (2.17%)    
Surgical and medical procedures     
Right Hip Osteoarthritis * [1]  0/22 (0.00%)  0 1/46 (2.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Hip Replacement Surgery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vehicle Gel Atralin Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/22 (59.09%)      25/46 (54.35%)    
Eye disorders     
Tearing of the eyes *  0/22 (0.00%)  0 1/46 (2.17%)  1
Blurry Vision *  1/22 (4.55%)  1 0/46 (0.00%)  0
Gastrointestinal disorders     
Hernia *  0/22 (0.00%)  0 1/46 (2.17%)  1
Vomiting *  0/22 (0.00%)  0 1/46 (2.17%)  2
Acid GI Reflux *  0/22 (0.00%)  0 1/46 (2.17%)  2
Nausea *  1/22 (4.55%)  1 0/46 (0.00%)  0
General disorders     
Numbness on Tongue *  1/22 (4.55%)  1 0/46 (0.00%)  0
Infections and infestations     
Upper Respiratory Tract Infection * [1]  6/22 (27.27%)  8 9/46 (19.57%)  11
Stomach Flu *  2/22 (9.09%)  2 2/46 (4.35%)  2
Urinary Tract Infection *  0/22 (0.00%)  0 1/46 (2.17%)  1
Head Lice * [2]  0/22 (0.00%)  0 1/46 (2.17%)  1
Stye * [3]  1/22 (4.55%)  1 0/46 (0.00%)  0
GI Distress *  1/22 (4.55%)  1 0/46 (0.00%)  0
Injury, poisoning and procedural complications     
Infection * [4]  0/22 (0.00%)  0 1/46 (2.17%)  1
Musculoskeletal and connective tissue disorders     
Back Disc Pain * [5]  0/22 (0.00%)  0 1/46 (2.17%)  1
Tendonitis * [6]  0/22 (0.00%)  0 1/46 (2.17%)  1
Arthritis Flare * [7]  0/22 (0.00%)  0 1/46 (2.17%)  1
Heel Spur * [8]  1/22 (4.55%)  1 0/46 (0.00%)  0
Nervous system disorders     
Headache *  0/22 (0.00%)  0 2/46 (4.35%)  2
Decreased Memory *  1/22 (4.55%)  1 0/46 (0.00%)  0
Psychiatric disorders     
Anxiety/Depression *  0/22 (0.00%)  0 2/46 (4.35%)  2
Respiratory, thoracic and mediastinal disorders     
Congestion * [9]  1/22 (4.55%)  1 5/46 (10.87%)  5
Asthma Flare *  0/22 (0.00%)  0 1/46 (2.17%)  1
Skin and subcutaneous tissue disorders     
Irritiated Skin * [10]  0/22 (0.00%)  0 5/46 (10.87%)  5
Eczema/Atopic Dermatitis *  2/22 (9.09%)  3 5/46 (10.87%)  6
Actinic Keratosis * [11]  2/22 (9.09%)  2 3/46 (6.52%)  4
Papular Inflammatory Flare *  0/22 (0.00%)  0 7/46 (15.22%)  9
Nail Disease * [12]  0/22 (0.00%)  0 2/46 (4.35%)  2
Basal Cell Carcinoma *  0/22 (0.00%)  0 1/46 (2.17%)  1
Inflamed Lesion/Cysts * [13]  0/22 (0.00%)  0 6/46 (13.04%)  6
Vascular disorders     
Hypertension * [14]  1/22 (4.55%)  1 0/46 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Nasal/Sinus Congestion, Cold, Upper Respiratory Infection
[2]
Exposure to head lice
[3]
Stye of upper eyelid
[4]
Possible infection of bx
[5]
Back problem (disc) L leg pain
[6]
R shoulder tendonitis
[7]
Arthritis flare L thumb
[8]
L Heel Spur
[9]
Nasal/Sinus Drainage, Congestion, Allergies
[10]
Facial Irritation, Sunburn
[11]
Flare, Development
[12]
Paronychia, Brittle Nails
[13]
Inflamed Cyst, Lesion, Bites, Cold Sores
[14]
Increased hypertension
Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lisa Maier
Organization: University of Michigan
Phone: 734-936-4192
Responsible Party: Lisa E. Maier, University of Michigan
ClinicalTrials.gov Identifier: NCT01125930     History of Changes
Other Study ID Numbers: Derm 616
First Submitted: May 13, 2010
First Posted: May 19, 2010
Results First Submitted: January 28, 2014
Results First Posted: July 16, 2014
Last Update Posted: July 16, 2014