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Patient-Reported Outcome Of Facial Erythema (PROOF) (PROOF)

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ClinicalTrials.gov Identifier: NCT01885000
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : January 13, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Rosacea
Erythema
Interventions Drug: once-daily brimonidine tartrate 0.5% gel
Drug: once-daily brimonidine tartrate vehicle gel
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description once-daily brimonidine tartrate 0.5% gel once-daily brimonidine tartrate vehicle gel
Period Title: Overall Study
Started 48 44
Completed 46 42
Not Completed 2 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             1
Protocol Violation             0             1
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle Total
Hide Arm/Group Description once-daily brimonidine tartrate 0.5% gel once-daily brimonidine tartrate vehicle gel Total of all reporting groups
Overall Number of Baseline Participants 48 44 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  77.1%
34
  77.3%
71
  77.2%
>=65 years
11
  22.9%
10
  22.7%
21
  22.8%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
Female
30
  62.5%
26
  59.1%
56
  60.9%
Male
18
  37.5%
18
  40.9%
36
  39.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
48
 100.0%
44
 100.0%
92
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Skin phototype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 44 participants 92 participants
Type I 3 6 9
Type II 34 27 61
Type III 11 11 22
[1]
Measure Description:

Type I: Individuals who never tan and always sunburn if exposed to any appreciable amount of sunlight, primarily red headed individuals and lighty complected blondes.

Type II: Individuals who frequently burn but are able to tan to a small degree after extended sun exposure.

Type III: Individuals who burn infrequently and tan readily.

1.Primary Outcome
Title Satisfaction With the Overall Study Treatment
Hide Description Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment
Time Frame Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subject who have answered the questionnaire at Day 8
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description:
once-daily brimonidine tartrate 0.5% gel
once-daily brimonidine tartrate vehicle gel
Overall Number of Participants Analyzed 46 42
Measure Type: Number
Unit of Measure: percentage of participants
69.6 40.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brimonidine Tartrate 0.5% Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0065
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Facial Appearance Since Starting the Treatment
Hide Description Percentage of subjects who answered A lot better/A little better to the question "what do you think about your facial appearance since starting the treatment?"
Time Frame Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who answered the questionnaire at Day 8
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description:
once-daily brimonidine tartrate 0.5% gel
once-daily brimonidine tartrate vehicle gel
Overall Number of Participants Analyzed 46 41
Measure Type: Number
Unit of Measure: percentage of participants
63 26.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brimonidine Tartrate 0.5% Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0217
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA)
Hide Description Percentage of participants with at least one grade improvement in the CEA
Time Frame Day 1, 3 hour after drug application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participantes with a CEA score at this timepoint
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description:
once-daily brimonidine tartrate 0.5% gel
once-daily brimonidine tartrate vehicle gel
Overall Number of Participants Analyzed 48 43
Measure Type: Number
Unit of Measure: percentage of participants
79.2 39.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brimonidine Tartrate 0.5% Gel, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subject Reporting a Treatment-related Adverse Event
Hide Description [Not Specified]
Time Frame From consent signature, up to Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
APT (All Patient Treated) population
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description:
once-daily brimonidine tartrate 0.5% gel
once-daily brimonidine tartrate vehicle gel
Overall Number of Participants Analyzed 48 44
Measure Type: Number
Unit of Measure: percentage of participants
29.2 15.9
Time Frame From consent signature, up to Day 8
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brimonidine Tartrate 0.5% Gel Vehicle
Hide Arm/Group Description once-daily brimonidine tartrate 0.5% gel once-daily brimonidine tartrate vehicle gel
All-Cause Mortality
Brimonidine Tartrate 0.5% Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brimonidine Tartrate 0.5% Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brimonidine Tartrate 0.5% Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/48 (31.25%)      9/44 (20.45%)    
Infections and infestations     
Rash pustular   1/48 (2.08%)  1 0/44 (0.00%)  0
Nervous system disorders     
Headache   1/48 (2.08%)  1 0/44 (0.00%)  0
Hypoesthesia   0/48 (0.00%)  0 1/44 (2.27%)  1
Skin and subcutaneous tissue disorders     
Erythema   4/48 (8.33%)  4 2/44 (4.55%)  2
Pain of skin   1/48 (2.08%)  1 0/44 (0.00%)  0
Pruritus   1/48 (2.08%)  1 1/44 (2.27%)  1
Rosacea   2/48 (4.17%)  2 1/44 (2.27%)  1
Skin burning sensation   0/48 (0.00%)  0 2/44 (4.55%)  2
Skin irritation   0/48 (0.00%)  0 1/44 (2.27%)  1
Skin tightness   3/48 (6.25%)  4 2/44 (4.55%)  3
Skin warm   2/48 (4.17%)  9 1/44 (2.27%)  2
Swelling face   1/48 (2.08%)  1 0/44 (0.00%)  0
Vascular disorders     
Flushing   2/48 (4.17%)  2 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
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.
Disclosure agreement covered by contract.
Results Point of Contact
Name/Title: Nabil Kerrouche
Organization: Galderma
Phone: +33 4 93 95 70 70
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01885000     History of Changes
Other Study ID Numbers: RD.03.SPR.29107
First Submitted: June 20, 2013
First Posted: June 24, 2013
Results First Submitted: November 17, 2016
Results First Posted: January 13, 2017
Last Update Posted: February 28, 2017