Sugarman Jeffrey L, Weiss Jonathan S, Tanghetti Emil A, Soung Jennifer, Yamauchi Paul S, Lin Tina, Harris Susan, Martin Gina, Pillai Radhakrishnan
University of California, San Francisco, USA.
Gwinnett Dermatology, PC, and Gwinnett Clinical Research Center, Inc, Snellville, Georgia, USA.
Cutis. 2019 Feb;103(2):111-116.
Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. Safety concerns have limited use to 2 to 4 weeks. The objective of our study was to investigate the safety and efficacy of once-daily halobetasol propionate (HP) lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was treatment success (at least a 2-grade improvement in baseline investigator global assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional assessments included improvement in psoriasis signs and symptoms, body surface area (BSA), and a composite score of IGA×BSA. Safety and treatment-emergent adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% demonstrated statistically significant superiority over vehicle as early as week 2 and also was superior in reducing psoriasis signs and symptoms and BSA involvement.
强效外用皮质类固醇（TCSs）是银屑病治疗的主要手段。由于安全问题，其使用期限限制在2至4周。我们研究的目的是通过2项多中心、随机、双盲、赋形剂对照的3期研究（N = 430），调查0.01%丙酸氯倍他索（HP）洗剂每日一次治疗中度至重度斑块状银屑病的安全性和有效性。参与者被随机分组（2:1），分别每日一次使用0.01% HP洗剂或赋形剂，持续8周，随后进行4周的随访。主要疗效评估为治疗成功（基线研究者整体评估[IGA]评分至少改善2级且评分为0[清除]或1[几乎清除]）。额外评估包括银屑病体征和症状的改善、体表面积（BSA）以及IGA×BSA综合评分。对安全性和治疗期间出现的不良事件（AE）进行全程评估。我们发现，0.01% HP洗剂早在第2周就显示出相对于赋形剂具有统计学意义的优越性，在减轻银屑病体征和症状以及BSA受累方面也更具优势。
