The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
708
CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Time frame: Week 12
Change From Baseline in Non-inflammatory Lesion Counts
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Change From Baseline in Inflammatory Lesion Counts
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Change From Baseline in Total Lesion Counts
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
Time frame: Baseline and Week 12
Percent Change From Baseline in Inflammatory Lesion (IL) Counts
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
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Gary M. Petrus, MD PA
Little Rock, Arkansas, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
San Diego Sports Medicine and Family Health Center
San Diego, California, United States
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
San Diego, California, United States
Southern California Dermatology
Santa Ana, California, United States
Clinical Science Institute
Santa Monica, California, United States
Memorial Research Medical Clinic dba / Orange County Research Center
Tustin, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Site 0190
Boca Raton, Florida, United States
...and 44 more locations
Time frame: Baseline and Week 12