Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Summary

To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Timeline

Start

2014-12-03

Primary completion

2017-01-12

Completion

2017-01-12

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Sarecycline; p < 0.0001; Least Squares Mean Difference -4.4 (95% CI -5.8 to -2.9); NCT02322866 ↗

registry analysis (superiority test); Placebo vs Sarecycline; p = 0.0038; Treatment Rate Difference 7.30 (95% CI 2.53 to 12.07); NCT02322866 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sarecycline	Small molecule	1.5 mg/kg	Oral

Indications