NCT02608450

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 708 (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 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CB-03-01 cream, 1%	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.
DRUG	Vehicle cream	Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.

Timeline

• Start date: 2016-01-21
• Primary completion: 2018-04-11
• Completion: 2018-04-11
• First posted: 2015-11-18
• Last updated: 2020-11-20
• Results posted: 2020-11-20

Locations

54 sites across 3 countries: United States, Georgia, Ukraine