A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris

The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Inclusion Criteria:

• At least 12 years of age.

• Facial acne, with:

  20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Skin diseases other than acne vulgaris
• Use of oral retinoids within 6 months of Baseline Visit
• Unwilling to discontinue all other treatments for facial acne
• Unwilling to avoid excessive swimming/sun exposure and use of cosmetics