Overview

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