NCT02322866

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

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 9 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Sarecycline	1.5 mg/kg/day taken orally at the same time each day.
DRUG	Placebo	Placebo-matching sarecycline tablets, taken orally at the same time each day.

Timeline

• Start date: 2014-12-03
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2014-12-23
• Last updated: 2019-02-01
• Results posted: 2018-05-07

Locations

57 sites across 1 country: United States