Green Lawrence J, Kerdel Francisco A, Cook-Bolden Fran E, Bagel Jerry, Lin Tina, Martin Gina, Pillai Radhakrishnan, Israel Robert, Ramakrishna Tage
J Drugs Dermatol. 2018 Oct 1;17(10):1062-1069.
Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks.
Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis.
Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout.
Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%.
Study did not include subjects with BSA greater than 12.
Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.
外用糖皮质激素（TCS）是银屑病治疗的主要药物；长期安全性问题限制了强效TCS连续使用2至4周。
研究0.01%丙酸氯倍他索洗剂治疗中度至重度斑块状银屑病的安全性和有效性。
两项多中心、随机、双盲、赋形剂对照的3期研究（N = 430）。受试者按2:1随机分为0.01%丙酸氯倍他索洗剂组或赋形剂组，每日一次，持续8周，治疗后随访4周。主要疗效评估：第8周时治疗成功（研究者整体评估[IGA]评分较基线至少改善2级且“清除”或“几乎清除”）。全程评估安全性和治疗中出现的不良事件（AE）。
早在第2周，0.01%丙酸氯倍他索洗剂就显示出相对于赋形剂有统计学意义的优越性。到第8周时，0.01%丙酸氯倍他索洗剂组分别有36.5%（研究1）和38.4%（研究2）的受试者治疗成功，而赋形剂组分别为8.1%和12.0%（P < 0.001）。0.01%丙酸氯倍他索洗剂在减轻银屑病体征和症状、体表面积（BSA）以及改善生活质量方面也更具优势。0.01%丙酸氯倍他索洗剂耐受性良好，无大于1%的与治疗相关的不良事件。
研究未纳入体表面积大于12的受试者。
0.01%丙酸氯倍他索洗剂可显著降低银屑病临床体征的严重程度，且不存在疗程延长带来的安全性问题。《药物皮肤病学杂志》。2018年；17(10):1062 - 1069。
