Abstract
Abstract not available.
Highlights
Sarecycline is a narrow-spectrum tetracycline-class antibiotic designed for the treatment of moderate-to-severe acne
Patients (n=483) aged 9 years or older with moderate-to-severe acne who completed one of two prior pivotal Phase III, double-blind, placebo-controlled, 12week trials in which they received sarecycline 1.5mg/kg/day or placebo once daily were continued on once daily sarecycline for up to 40 weeks Study visits: weeks 2, 6, 12,18, 24, 32 and 40
The primary assessment was the safety of sarecycline 1.5mg/kg/day for 40 weeks as indicated by adverse events (AEs), vital signs, electrocardiograms, clinical laboratory tests, and physical examinations
Summary
Sarecycline is a narrow-spectrum tetracycline-class antibiotic designed for the treatment of moderate-to-severe acne. Sarecycline’s narrow-spectrum anti-bacterial activity and lipophilicity may minimize side effects commonly associated with broad-spectrum tetracyclines, such as minocycline and doxycycline. We report the results of 2 identically designed, phase 3 pivotal trials, SC1401 and SC1402, to evaluate the efficacy and safety of oncedaily sarecycline (n=2002)
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