P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

• Status: Completed
• Trial end date: 2016-12-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: Chiltern International Inc.

Criteria

Inclusion Criteria:

• Moderate to severe acne

• Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones) on the face

• Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

Exclusion Criteria:

• Women of child-bearing potential who are pregnant, nursing, considering becoming pregnant

• Any dermatologic condition that could interfere with clinical evaluations including severe, recalcitrant cystic acne