NCT02667444

P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,330 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 9 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	SB204 4%	Applied topically once daily
DRUG	Vehicle Gel	Applied topically one daily

Timeline

• Start date: 2016-02-19
• Primary completion: 2016-12-01
• Completion: 2016-12-09
• First posted: 2016-01-29
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

55 sites across 1 country: United States