The purpose of this study is to evaluate the superiority in efficacy and assess safety and tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active components or the vehicle for the treatment of acne.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
726
Investigator's Global Assessment (IGA)
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12
Time frame: week 12
Absolute change in lesion count (separately for inflammatory and non-inflammatory)
Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
Time frame: baseline and week 12
Percentage change from Baseline in lesion count on the face at Week 12
Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
Time frame: Baseline and week 12
assessments of IGA at each time point
Supportive efficacy variables are the assessments of IGA percentage change at each time point during the treatment period, namely at Weeks 4, and 8.
Time frame: baseline, week 4, 8
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once a day topical cream
once a day topical cream
once a day topical cream
Orange County Research Institute
Anaheim, California, United States
Core Healthcare Group
Cerritos, California, United States
eStudySite
Chula Vista, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Dermatology Research Associates
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
Empire Clinical Research
Upland, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
MOORE Clinical Research, Inc
Brandon, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
...and 24 more locations