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

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, laboratory testing, and tolerability.

RESULTS

One hundred fifty-three subjects were randomized to vehicle (n=52), SB204 1% (n=51), or SB204 4% (n=50). When compared to vehicle, subjects treated with SB204 1% and SB204 4% had significantly greater mean percent reduction in noninflammatory lesions from baseline and subjects treated with SB204 4% had a significantly greater mean percent reduction in inflammatory lesion count from baseline at Week 12. There were no significant differences in the IGA success rates between groups. Both concentrations of SB204 were safe and well-tolerated.

CONCLUSIONS

When compared to vehicle, both SB204 1% and SB204 4% significantly decreased the percentage of noninflammatory lesions and SB204 4% also significantly decreased the percentage of inflammatory lesions in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 1% and SB204 4% was safe and well-tolerated. Registry: clinicaltrials.gov (NCT01844752).