Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris.

ABSTRACT:

Objective

To compare efficacy, tolerability, and safety of two concentrations of topical SB204 and vehicle twice daily for 12 weeks in the treatment of acne vulgaris.

Design

Randomized, double-blind, placebo-controlled, three-arm, Phase 2 study.

Setting

Dominican Republic, Panama, and Honduras.

Participants

Subjects with acne, age 12 to 40, with 25 to 70 noninflammatory lesions, 20 to 40 inflammatory lesions, and a baseline Investigator's Global Assessment score of mild, moderate, or severe.

Measurements

The primary efficacy assessment was the absolute change in noninflammatory lesion counts. Other assessments included inflammatory lesion counts, success on dichotomized Investigator's Global Assessment, reported adverse events, physical examinations, lab

SUBMITTER: Baldwin H 

PROVIDER: S-EPMC5022991 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature