Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Summary

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

Timeline

Start

2014-12-18

Primary completion

2017-02-01

Completion

2017-02-01

Outcome

Met primary endpoint

registry analysis (superiority test); Sarecycline vs Placebo; p < 0.0001; Least Squares Mean Difference -5.2 (95% CI -6.7 to -3.6) NCT02320149 ↗

registry NUMBER Sarecycline: 21.9 percentage of participants NUMBER Placebo: 10.5 percentage of participants analysis (superiority test); Sarecycline vs Placebo; p < 0.0001 NCT02320149 ↗

Drugs

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

Indications