NCT02242760

P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Novan, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Detailed description

A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	SB204 2%	Applied topically twice daily
DRUG	SB204 4%	Applied topically daily
DRUG	Vehicle Gel	Applied topically twice and once daily

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2014-09-17
• Last updated: 2023-05-31
• Results posted: 2023-05-31

Locations

20 sites across 1 country: United States