Journal of Clinical and Aesthetic Dermatology 杂志投稿-刊鹿论文编译

Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study.

Abstract:

Objective: We sought to evaluate the safety, tolerability, and patterns of use for the once-daily oral, narrow-spectrum antibiotic sarecycline in patients with moderate-to-severe acne vulgaris during a 40-week Phase III, multicenter, open-label extension study. Participants: Patients aged nine years or older with moderate-to-severe acne who completed one of two prior Phase III, double-blind, placebo-controlled, 12-week trials in which they received sarecycline 1.5mg/kg/day or placebo were included. Measurements: 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. Patterns of sarecycline use were a secondary assessment. Results: The safety population included 483 patients; 354 patients (73.3%) completed the study. The most common reasons for premature discontinuation were withdrawal by the patient (14.5%), lost to follow-up (7.9%), and AEs (2.5%). The most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). Clinical laboratory evaluations suggested no clinically meaningful differences between the treatment sequences. Rates of TEAEs commonly associated with other tetracycline antibiotics include dizziness (0.4%) and sunburn (0.2%), and for gastrointestinal TEAEs, nausea (2.1%), vomiting (1.9%), and diarrhea (1.0%). Also reported herein are the results of a Phase I phototoxicity study. Conclusion: Patients aged nine years or older with moderate-to-severe acne vulgaris who received sarecycline once daily for up to 40 weeks showed low rates of TEAEs, with nasopharyngitis, upper-respiratory-tract infection, headache, and nausea being the only TEAEs reported by 2% or more of patients. No clinically meaningful safety findings were noted. ClinicalTrials.gov Registration: NCT02413346.

Author Listing： David M Pariser;Lawrence J Green;Edward L Lain;Carsten Schmitz;Amy S Chinigo;Brian McNamee;David R Berk

Volume： 12 11

Pages： \n E53-E62\n

DOI： 10.25251/skin.4.supp.87

Language： English

Journal： The Journal of clinical and aesthetic dermatology

Journal of Clinical and Aesthetic Dermatology

影响因子：0.0

是否综述期刊：否

是否OA：否

是否预警：不在预警名单内

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ISSN：1941-2789

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收录数据库：Scopus收录

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出版社：Matrix Medical Communications

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自引率	0.0%
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偏重研究方向	Medicine-Dermatology
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WOS期刊SCI分区（2021-2022年最新版）

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