P3 Long Term Safety Study of Once Daily SB204 in Acne

• Status: Completed
• Trial end date: 2017-04-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open label long-term safety (LTS) study to be conducted in approximately 600 subjects with acne vulgaris.

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

Details

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

Criteria

Inclusion Criteria:

• Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

Exclusion Criteria:

• Terminated early from an SB204 Phase 3 pivotal study for any reason

• Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants stopping study drug application

• Have used medications or vitamins during the 12 weeks immediately preceding this study which were reported to exacerbate acne.