NCT00714714

Evaluation of Irritation That Could be Caused 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: 25 (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 on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two 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 two consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. 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	Adapalene Gel	adapalene gel 0.3% topically applied daily in a split-face model for two weeks
DRUG	Tretinoin Gel	Tretinoin 0.1% topically applied daily in a split face model for two weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-07-14
• Last updated: 2012-02-15
• Results posted: 2009-09-02

Locations

1 site across 1 country: United States