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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02672332
Study type Interventional
Source Novan, Inc.
Contact
Status Completed
Phase Phase 3
Start date February 22, 2016
Completion date December 21, 2016

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