Department of Pharmacotherapy and Translational Research, University of Florida, College of Pharmacy, Gainesville, Florida, USA.
Department of Pharmacotherapy and Translational Research, University of Florida, College of Pharmacy, Gainesville, Florida, USA.
Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose of this article was to review the clinical data regarding the safety and efficacy of topical clascoterone for the treatment of acne vulgaris in male and female subjects aged >12 years.
A literature search of PubMed, EMBASE, and MEDLINE was conducted for clinical trials published between January 2014 and March 2021 in the English language using the key words Winlevi, clascoterone, and acne vulgaris. Articles were selected if they were related to the approval by the US Food and Drug Administration of clascoterone or provided novel data regarding this drug entity.
Two Phase III randomized controlled trials (NCT02608450 and NCT02608476) were ultimately selected, as these trials provided pivotal information to the US Food and Drug Administration for the approval of topical clascoterone.
The findings of this review show that topical clascoterone is likely an effective and safe option for the treatment of acne vulgaris. It offers efficacy rates similar to those of current medications through a novel mechanism of action. Its place in therapy remains unclear, but it might be placed ahead of other androgen receptor antagonists such as spironolactone due to its avoidance of systemic side effects.
寻常痤疮是一种在青少年中开始普遍存在的疾病，男女皆可发病。它通常持续存在且对多种治疗方法有抗性。尽管有多种药物可用于治疗，但这些治疗方法存在许多不良反应和风险，并且 40 年来一直没有新作用机制的药物问世。氯螺内酯是一种最近批准的外用痤疮药物，是自异维 A 酸以来第一种具有新作用机制的药物。本文旨在回顾外用氯螺内酯治疗 12 岁以上男性和女性寻常痤疮的安全性和疗效的临床数据。
使用关键词 Winlevi、clascoterone 和 acne vulgaris，对 2014 年 1 月至 2021 年 3 月期间在英文文献中发表的临床试验进行了 PubMed、EMBASE 和 MEDLINE 文献检索。如果文章与美国食品和药物管理局批准氯螺内酯相关，或者提供了关于该药物实体的新数据，则选择这些文章。
最终选择了两项 III 期随机对照试验（NCT02608450 和 NCT02608476），因为这些试验为美国食品和药物管理局批准外用氯螺内酯提供了重要信息。
本综述的结果表明，外用氯螺内酯可能是治疗寻常痤疮的一种有效且安全的选择。它通过新的作用机制提供了与现有药物相似的疗效。它在治疗中的地位尚不清楚，但由于其避免了全身副作用，它可能优于其他雄激素受体拮抗剂，如螺内酯。
