Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face

Condition(s) targeted: Acne Vulgaris

Intervention: Tretinoin Facial Gel (Drug); Adapalene/Benzoyl Peroxide Facial Gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Valeant Pharmaceuticals International, Inc.

Official(s) and/or principal investigator(s):
David Lineberry, Study Director, Affiliation: Valeant Pharmaceuticals International, Inc.

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.

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Facial Irritation and Cutaneous Effects

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy volunteers

- Before screening, subjects (or legally authorized representative) must read and sign

the IRB approved Informed Consent Form (includes HIPPA and Photo release)

- Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator

to have healthy skin

- Subject's bilateral facial skin must be clear of any confounding irritation, rashes,

acne, rosacea, etc. prior to the study

- Subject must be free of systemic retinoids for at least 2 months

- Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide

or systemic steroids for 1 month prior to study start

- All other topical medications to face (e. g., steroids, antimicrobials, salicylic acid

and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation

- Subjects will not apply any emollients and cosmetics to the facial area 24 hours

prior to study initiation

- Subject must not be planning to become pregnant or nursing before entering the study

and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms. Exclusion Criteria:

- Subjects who are pregnant or nursing

- Subjects who have a grade 1 or more for facial erythema

- Subjects who exhibit any skin condition (i. e., atopic dermatitis, seborrheic

dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy

- Subjects who have a history of hypersensitivity to any of the formulation components

- Subjects who have received any experimental drug or used any experimental device 30

days prior to initiation of study therapy

- Subjects who have excessive facial hair that may obstruct or hinder the evaluation of

any reactions

- Subjects who use any known photosensitizing agents

- Subjects who presently have skin cancer or actinic keratosis on the face

Skin Study Center, Broomall, Pennsylvania 19008, United States

FDA's Drug Finder

Starting date: July 2009
Last updated: February 14, 2012