CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 601 enrolled
Drug / intervention
SB204 4%drug
Likely dose
SB204 4% topical, once dailyAI-extracted
Key inclusion· 1
  • ✓Completion of 12 weeks of treatment in either NI-AC301 or NI-AC302 pivotal trial
Key exclusion· 3
  • ✕Early termination from an SB204 Phase 3 pivotal study for any reason
  • ✕Ongoing adverse event at Week 12 visit from prior study that warrants stopping study drug application
  • ✕Use of medications or vitamins during the 12 weeks prior to enrollment that were reported to exacerbate acne

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02798120
NCT02798120Phase 3Completed
CompareCT.gov

A Phase 3 Multi-Center, Open Label Study Evaluating the Long Term Safety of SB204 Once Daily in the Treatment of Acne Vulgaris

Novan, Inc.·interventional·Posted Jun 14, 2016·Updated May 12, 2023

In Brief

A Phase 3 clinical trial evaluating SB204 4% for Acne Vulgaris. Completed, enrolled 601 participants across 69 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
CollaboratorsChiltern International Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartMay 12, 2016
Primary CompletionApr 1, 2017
Study CompletionApr 27, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.0 years ago

Interventions

SB204 4%drug

Open label, topical SB204 4%