At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 732 enrolled
Drug / intervention
CB-03-01 cream, 1% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
In Brief
A Phase 3 clinical trial evaluating CB-03-01 cream, 1% and Vehicle cream for Acne Vulgaris. Completed, enrolled 732 participants across 52 sites in 6 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesBulgaria, Georgia, Poland, Romania, Serbia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionFeb 2018
TodayJul 2026
First PostedNov 18, 2015
Enrollment StartNov 16, 2015
Primary CompletionFeb 21, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.6 years ago
Interventions
CB-03-01 cream, 1%drug
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 creamdrug
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.