ArticleDermatology and therapy2025
Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up.
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Acne: epidemiology, risk factors, pathogenesis, management and cutting-edge research.Signal transduction and targeted therapy · 2026Review
- Review
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).
methodsThe 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 lesion counts.
resultsThree hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error [SE]) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: - 24.3 (0.7) vs. - 15.4 (1.0) (p < 0.001) and - 73.2% vs. - 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 [51.1%]) responded well to a second 12W course of sarecycline with a mean (standard deviation [SD]) reduction of - 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts.
conclusionsSarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population. CLINICAL
trial registrationChinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .
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