Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
Drug: Tretinoin Facial Gel
Drug: Adapalene/Benzoyl Peroxide Facial Gel
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model|
- Facial Irritation and Cutaneous Effects [ Time Frame: three weeks ] [ Designated as safety issue: No ]Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
|Study Start Date:||July 2009|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Tretinoin & Adapalene-Benzoyl Peroxide
Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Drug: Tretinoin Facial Gel
A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.
Other Name: Retin-A Micro Gel 0.04% PumpDrug: Adapalene/Benzoyl Peroxide Facial Gel
A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Other Name: Epiduo Gel
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.
|United States, Pennsylvania|
|Skin Study Center|
|Broomall, Pennsylvania, United States, 19008|
|Study Director:||David Lineberry||Valeant Pharmaceuticals International, Inc.|