A Study of Different Use Regimens Using Two Acne Treatments

Condition(s) targeted: Acne Vulgaris

Intervention: benzoyl peroxide wash (Drug); Tretinoin gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Valeant Pharmaceuticals International, Inc.

Official(s) and/or principal investigator(s):
Ana Rossi, MD, Study Director, Affiliation: Johnson & Johnson Consumer and Personal Products Worldwide

A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Official title: A Clinical Assessment of the Use of RETIN-A MICRO (Tretinoin Gel) Microsphere, 0.04% in a Pump Dispenser and a 5% Benzoyl Peroxide Wash Used in the Morning Compared to the Use of RETIN-A MICRO 0.04% Pump Nightly and a 5% Benzoyl Peroxide Wash in the Morning For the Treatment of Facial Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Total Facial Acne Lesion Count

Secondary outcome:

Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals

Measurement of Success

Detailed description: Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0. 04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and non-pregnant or non-nursing females, 12 years or older, with facial acne

vulgaris;

- Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules);

- Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed

comedones);

- Must have at least a rating of grade 3 on the Investigator Global severity scale at

baseline Exclusion Criteria:

- Known sensitivity to any of the ingredients in the study medication;

- Any nodulocystic acne lesions;

- Use of acne devices or systemic therapy with antibiotics within two months prior to

start and throughout the duration of the study;

- Use of systemic therapy with retinoids within four months prior to study start and

throughout the duration of the study;

- Topical use of retinoids within two weeks prior to study start and throughout the

duration of the study;

- Topical use of antibiotics, steroids and/or other non-retinoid topical acne products

within two weeks prior to study start and throughout the duration of the study;

- If subject is taking birth control pills, she must be stabilized for at least three

months prior to study start;

- History of evidence of other skin conditions or diseases that may require concurrent

therapy or may interfere with the evaluation of the study medication;

- Any significant medical conditions that could confound the interpretation of the

study;

- Excessive facial hair that may interfere with evaluations;

- No use of tanning booths, sun lamps, etc.

Skin Care Research, Inc., Boca Raton, Florida 33486, United States

International Dermatology Research, Inc., Miami, Florida 33144, United States

Gwinnett Clinical Research, Snellville, Georgia 30078, United States

Derm Research, PLLC, Louisville, Kentucky 40217, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States

DermResearch Center of New York, Stony Brook, New York 11790, United States

Dermatology Research Associates, Cincinnatti, Ohio 45230, United States

Yardley Dermatology Associates, Yardley, Pennsylvania 19067, United States

DermResearch, Inc., Austin, Texas 78759, United States

Education & Research Foundation, Inc., Lynchburg, Virginia 24501, United States

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States

FDA's Drug Finder

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