Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 162
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model

Interventions: intervention 1: Tretinoin Facial Gel intervention 2: Adapalene/Benzoyl Peroxide Facial Gel
Intervention descriptions: intervention 1: A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks. intervention 2: 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

Protocol document: