NCT01631474

A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Intrepid Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CB-03-01	Topical cream, applied once a day
DRUG	Vehicle	Topical cream, applied once or twice a day
DRUG	CB-03-01	Topical cream, applied twice a day

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-06-29
• Last updated: 2020-11-16
• Results posted: 2020-11-16

Locations

13 sites across 1 country: United States