NCT02682264

An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: Cassiopea SpA · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a multicenter, open label, long-term extension study for CB-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\]. Participants applies the active medication (CB-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator AND desired by the participant, truncal acne for nine additional months of treatment. Thus, overall participants were exposed to CB-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the Phase 3 pivotal study and an additional nine months in this long-term safety study). Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk). Participants were rolled over from the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CB-03-01 cream, 1%	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.

Timeline

• Start date: 2016-03-09
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2016-02-15
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

74 sites across 7 countries: United States, Bulgaria, Georgia, Poland, Romania, Serbia, Ukraine