A Study of Different Use Regimens Using Two Acne Treatments

Phase 4

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Same time of day	benzoyl peroxide wash	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Same time of day	Tretinoin gel	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Different times of day	benzoyl peroxide wash	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Different times of day	Tretinoin gel	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Facial Acne Lesion Count	Baseline to Week 12	Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals	Baseline to Week 12	Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Measurement of Success	Baseline to Week 12	Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.

Locations (12): International Dermatology Research, Inc.
🇺🇸
Miami, Florida, United States
DermResearch Center of New York
🇺🇸
Stony Brook, New York, United States
Derm Research, PLLC
🇺🇸
Louisville, Kentucky, United States
Gwinnett Clinical Research
🇺🇸
Snellville, Georgia, United States
Skin Care Research, Inc.
🇺🇸
Boca Raton, Florida, United States
Dermatology Research Associates
🇺🇸
Cincinnatti, Ohio, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
Yardley Dermatology Associates
🇺🇸
Yardley, Pennsylvania, United States
Education & Research Foundation, Inc.
🇺🇸
Lynchburg, Virginia, United States
DermResearch, Inc.
🇺🇸
Austin, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States