CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
363
Dermatology Research Associates
Los Angeles, California, United States
Therapeutics Clinical Research
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Investigator's Global Assessment (IGA) "Success" - Week 12
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Time frame: Baseline and Week 12
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
Time frame: Baseline and Week 8
Percent Change in Lesion Counts - Weeks 8 and 12
Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
Time frame: Week 8 and Week 12
IGA "Success" - Week 8
Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
Time frame: Baseline and Week 8
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
Time frame: Weeks 4, 8, and 12
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International Clinical Research - US, LLC
Sanford, Florida, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Indiana Clinical Trials Center
Plainfield, Indiana, United States
Marina I. Peredo, M.D., PC
Smithtown, New York, United States
Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
Hershey, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
...and 3 more locations