Overview

This trial is active, not recruiting.

Condition acne vulgaris
Treatment sb204 4%
Phase phase 3
Sponsor Novan, Inc.
Collaborator Chiltern International Inc.
Start date May 2016
End date June 2017
Trial size 605 participants
Trial identifier NCT02798120, NI-AC303

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SB204 4% once daily
sb204 4% NVN1000
Open label, topical SB204 4%

Primary Outcomes

Measure
safety assessments (Reported adverse events)
time frame: Week 40/End of Treatment

Secondary Outcomes

Measure
Tolerability assessment (Analysis of tolerability scores at each visit through end of treatment)
time frame: Week 40/End of Treatment

Eligibility Criteria

Male or female participants from 9 years up to 99 years old.

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.

Additional Information

Official title A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novan, Inc..