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

Bausch Health

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Adapalene/Benzoyl Peroxide Facial Gel

Drug: Tretinoin Facial Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952523

CA-P-7190

Details and patient eligibility

About

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.

Full 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.

Enrollment

162 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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