At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,034 enrolled
Drug / intervention
Sarecycline +1 moredrug
Likely dose
Sarecycline 1.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Sarecycline and Placebo for Acne Vulgaris. Completed, enrolled 1,034 participants across 57 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
CollaboratorsAllergan
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionJan 2017
TodayJul 2026
First PostedDec 23, 2014
Enrollment StartDec 3, 2014
Primary CompletionJan 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.5 years ago
Interventions
Sarecyclinedrug
1.5 mg/kg/day taken orally at the same time each day.
Placebodrug
Placebo-matching sarecycline tablets, taken orally at the same time each day.