CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,330 enrolled
Drug / intervention
SB204 4% +1 moredrug
Likely dose
SB204 4% gel applied topically once dailyAI-extracted
Key inclusion· 3
  • ✓Diagnosis of moderate to severe acne
  • ✓25–70 non-inflammatory lesions (comedones) on face
  • ✓20–40 inflammatory lesions (papules/pustules)
Key exclusion· 2
  • ✕Pregnant, nursing, or planning pregnancy
  • ✕Dermatologic conditions interfering with clinical evaluation or severe cystic acne

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

Search/NCT02667444
NCT02667444Phase 3Completed
CompareCT.gov

A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of Once Daily SB204 and Vehicle Gel in the Treatment of Acne Vulgaris

Novan, Inc.·interventional·Posted Jan 29, 2016·Updated Jul 24, 2023

In Brief

A Phase 3 clinical trial evaluating SB204 4% and Vehicle Gel for Acne Vulgaris. Completed, enrolled 1,330 participants across 55 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 29, 2016
Enrollment StartFeb 19, 2016
Primary CompletionDec 1, 2016
Study CompletionDec 9, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago

Interventions

SB204 4%drug

Applied topically once daily

Vehicle Geldrug

Applied topically one daily