Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up.

ABSTRACT:

Introduction

This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).

Methods

The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9-45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesi

SUBMITTER: Zhang J 

PROVIDER: S-EPMC12549459 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature