At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 609 enrolled
Drug / intervention
CB-03-01 cream, 1%drug
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.
An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects With Acne Vulgaris
In Brief
A Phase 3 clinical trial evaluating CB-03-01 cream, 1% for Acne Vulgaris. Completed, enrolled 609 participants across 74 sites in 7 countries.
Detailed Summary
The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesBulgaria, Georgia, Poland, Romania, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionAug 2018
TodayJul 2026
First PostedFeb 15, 2016
Enrollment StartMar 9, 2016
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.4 years ago
Interventions
CB-03-01 cream, 1%drug
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.