Dataset Information

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, 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).

SUBMITTER: Baldwin H

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

REPOSITORIES: biostudies-literature

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

Baldwin Hilary H Blanco Daisy D McKeever Charles C Paz Nelly N Vasquez Ynca Nina YN Quiring John J Enloe Carolyn C De León Emily E Stasko Nathan N

The Journal of clinical and aesthetic dermatology 20160801 8

<h4>Objective</h4>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.<h4>Design</h4>Randomized, double-blind, placebo-controlled, three-arm, Phase 2 study.<h4>Setting</h4>Dominican Republic, Panama, and Honduras.<h4>Participants</h4>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 m ...[more]

PMID: 27672413

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Project description:ImportanceMolluscum contagiosum (MC) is a highly contagious skin condition. Lesions may persist for months to years, and no US Food and Drug Administration-approved medications are currently available in the US.ObjectiveTo assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of MC.Design, setting, and participantsThis was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted MC or with MC only in the periocular area were excluded.InterventionsPatients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks.Main outcomes and measuresThe primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021.ResultsA total of 891 participants were randomized, 444 to berdazimer, 10.3% (mean [range] age, 6.6 [0.9-47.5] years; 228 [51.4%] male; 387 [87.2%] White individuals), and 447 to vehicle (mean [range] age, 6.5 [1.3-49.0] years; 234 [52.3%] female; 382 [85.5%] White individuals). In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% (397 patients) in the vehicle group had a lesion count performed at week 12. At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8; P < .001) with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of MC clearance compared with 8.9% (40 patients) of the vehicle group. Adverse event rates were low. The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group. The most common local skin reaction was mild to moderate erythema.Conclusions and relevanceUse of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates.Trial registrationClinicalTrials.gov Identifier: NCT04535531.

Dataset Information

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

Publications

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

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