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口服丝柔四环素治疗躯干痤疮:两项3期临床试验的汇总结果

Management of Truncal Acne With Oral Sarecycline: Pooled Results from Two Phase-3 Clinical Trials.

作者信息

Del Rosso James Q, Stein Gold Linda, Baldwin Hilary, Harper Julie C, Zeichner Joshua, Obagi Sabine, Graber Emmy, Jimenez Xochitl, Vicente Francisco Hernandez, Grada Ayman

出版信息

J Drugs Dermatol. 2021 Jun 1;20(6):634-640. doi: 10.36849/JDD.2021.6204.

Abstract

BACKGROUND

Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris.

METHOD

Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12.

RESULTS

Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne. J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204.

摘要

背景

寻常痤疮是一种常见的皮肤病,会影响面部、胸部和背部。虽然至少50%的患者存在躯干痤疮,但临床研究主要集中在面部痤疮。1,2 迄今为止,针对躯干痤疮的治疗方法很少得到评估。丝柔四环素是一种窄谱、第三代四环素类口服药物,已被批准用于治疗痤疮。关键的3期研究表明,丝柔四环素对于中度至重度寻常痤疮是一种安全、耐受性良好且有效的治疗方法。

方法

对两项3期研究中丝柔四环素治疗躯干痤疮的结果进行汇总分析。在第3、6、9和12周评估研究者整体评估(IGA)成功率。

结果

在第3周(分别为11.84%对7.71%;P = 0.0192)、第6周(分别为18.81%对14.03%;P = 0.0390)和第12周(分别为33.42%对20.77%;P < 0.0001)时,与安慰剂相比,丝柔四环素治疗胸部痤疮的IGA成功率显著更高。在第3周(分别为12.13%对7.04%;P = 0.0023)、第6周(分别为18.42%对14.34%;P = 0.0412)、第9周(分别为29.05%对19.88%;P = 0.0004)和第12周(分别为33.07%对21.91%;P < 0.0001)时,与安慰剂组相比,丝柔四环素治疗背部痤疮的IGA成功率也显著更高。结论:治疗后3周内观察到丝柔四环素对躯干痤疮有效,支持丝柔四环素作为口服治疗中度至重度躯干痤疮的最佳选择。《药物皮肤病学杂志》。2021年;20(6):634 - 640。doi:10.36849/JDD.6204 。

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