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. 2016 Aug;9(8):12-8.
Epub 2016 Aug 1.

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

Hilary Baldwin  1 , Daisy Blanco  2 , Charles McKeever  3 , Nelly Paz  4 , Ynca Nina Vasquez  5 , John Quiring  6 , Carolyn Enloe  7 , Emily De León  7 , Nathan Stasko  7
Affiliations

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

Hilary Baldwin et al. J Clin Aesthet Dermatol. 2016 Aug.

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, 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).

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Figures

Figure 1.
Figure 1.
Subject disposition in the ITT population
Figure 2.
Figure 2.
Mean percentage change: noninflammatory lesion count over time (ITT Population). *p<0.05
Figure 3.
Figure 3.
Mean percentage change: inflammatory lesion count over time (ITT Population). *p<0.05
Figure 4.
Figure 4.
Photographs from Baseline and Week 12 from subjects randomized to SB204 4%
Figure 4.
Figure 4.
Photographs from Baseline and Week 12 from subjects randomized to SB204 4%
Figure 4.
Figure 4.
Photographs from Baseline and Week 12 from subjects randomized to SB204 4%
Figure 4.
Figure 4.
Photographs from Baseline and Week 12 from subjects randomized to SB204 4%
See this image and copyright information in PMC

References

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