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

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.

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.

Key Inclusion Criteria:

• At least 12 years of age at the time of enrollment

• Facial acne, with:

  1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts);
  2. 20-100 noninflammatory facial lesions (open and closed comedones);
  3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter);
  4. Investigator's Global Assessment (IGA) acne score of 3 or 4.

Key Exclusion Criteria:

• Females who are pregnant or breast-feeding
• Skin diseases other than acne vulgaris
• Use of other topical or systemic treatments for acne
• Other significant medical conditions or clinically significant abnormal laboratory test results.