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.


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


METHODS
Dominican Republic, Panama, and Honduras.


METHODS
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.


METHODS
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).
Acne Research and Treatment Center, Morristown, New Jersey;
Hilary
H
Baldwin
Instituto Dermatológico y Cirugía de Piel, Santo Domingo, Dominican Republic;
Daisy
D
Blanco
Hospital Punta Pacifica, Panama City, Panama;
Charles
C
McKeever
Hospital y Clínica Bendaña, San Pedro Sula, Honduras;
Nelly
N
Paz
Instituto Dermatológico y Cirugía de Piel, San Cristobal, Dominican Republic;
Ynca Nina
YN
Vasquez
QST Consultations, Allendale, Michigan;
John
J
Quiring
Novan, inc, Durham, North Carolina.
Carolyn
C
Enloe
Novan, inc, Durham, North Carolina.
Emily
E
De León
Novan, inc, Durham, North Carolina.
Nathan
N
Stasko
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