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Cumulative Irritation Potential of 828 Ointment

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: NCT00767455
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor)
Condition Healthy Volunteers
Intervention Device: HP828-101
Enrollment 59
Recruitment Details Healthy volunteers >= 18 years of age
Pre-assignment Details  
Arm/Group Title HP828-101 vs. Negative Control vs. Positive Control
Hide Arm/Group Description Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
Period Title: Overall Study
Started 59
Completed 40
Not Completed 19
Reason Not Completed
Investigator error             19
Arm/Group Title HP828-101 vs. Negative Control vs. Positive Control
Hide Arm/Group Description each subject was their own control and received patches of all (test article, negative control, and positive control)
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
<=18 years
0
   0.0%
Between 18 and 65 years
58
  98.3%
>=65 years
1
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
41.2  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
43
  72.9%
Male
16
  27.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
1.Primary Outcome
Title Presence of Cumulative Irritation
Hide Description Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title HP828-101 Negative Control Positive Control
Hide Arm/Group Description:
Intervention test article
Johnson's Baby Oil
Sodium Lauryl Sulfate
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: units on a scale
163.0 109.0 2073.0
Time Frame 22 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HP828-101 vs. Negative Control vs. Positive Control
Hide Arm/Group Description each subject was their own control and received patches of all (test article, negative control, and positive control)
All-Cause Mortality
HP828-101 vs. Negative Control vs. Positive Control
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HP828-101 vs. Negative Control vs. Positive Control
Affected / at Risk (%) # Events
Total   0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HP828-101 vs. Negative Control vs. Positive Control
Affected / at Risk (%) # Events
Total   4/59 (6.78%)    
Skin and subcutaneous tissue disorders   
Tape Reaction * 1 [1]  4/59 (6.78%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
None of the adverse events were related to the test article. The four (4) subjects with a moderate adverse event due to tape irritation were discontinued from the study
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: Jaime Dickerson, PhD
Organization: Smith & Nephew Biotherapeutics
Phone: 817-302-3914
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00767455     History of Changes
Other Study ID Numbers: 828-101-09-010
First Submitted: October 4, 2008
First Posted: October 7, 2008
Results First Submitted: October 9, 2013
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014