NCT01289574

Topical ASC-J9 Cream for Acne

Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Safety and Efficacy of 0.1% and 0.025% ASC-J9 Creams Applied Topically Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: AndroScience Corp · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.

Detailed description

Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	ASC-J9	Cream for twice daily topical application to the face

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2011-02-03
• Last updated: 2014-08-01
• Results posted: 2014-07-25

Locations

7 sites across 2 countries: United States, Taiwan