Topical ASC-J9 Cream for Acne

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AndroScience Corp
• Collaborator: Orient Europharma Co., Ltd.

Criteria

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.