NCT00919191

Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tretinoin gel	Tretinoin gel 0.04% used once daily in a split-face model
DRUG	Adapalene and Benzoyl peroxide	Adapalene .1% and Benzoyl peroxide 2.5%

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-06-12
• Last updated: 2012-02-15
• Results posted: 2010-03-10

Locations

1 site across 1 country: United States