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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
247
5% benzoyl peroxide wash
0.04% tretinoin gel
Skin Care Research, Inc.
Boca Raton, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Gwinnett Clinical Research
Snellville, Georgia, United States
Change From Baseline in Total Facial Acne Lesion Count
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.
Time frame: Baseline to Week 12
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
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).
Time frame: Baseline to Week 12
Measurement of Success
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.
Time frame: Baseline to Week 12
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Derm Research, PLLC
Louisville, Kentucky, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
DermResearch Center of New York
Stony Brook, New York, United States
Dermatology Research Associates
Cincinnatti, Ohio, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, United States
DermResearch, Inc.
Austin, Texas, United States
...and 2 more locations