Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.
Department of Dermatology, VA Medical Center, Miami, FL, USA.
Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.
Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.
The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.
Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach.
Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
ClinicalTrials.gov identifier, NCT02899962.
寻常型银屑病通常采用局部皮质类固醇和维生素 D 类似物治疗。虽然强效和超强效局部皮质类固醇在清除银屑病方面非常有效，治疗持续时间较短，但治疗停止后症状通常会复发，因此需要长期的疾病管理策略。卡泊三醇和倍他米松二丙酸酯（Cal/BD 泡沫）的泡沫制剂，由 50μg/g 的卡泊三醇和 0.5mg/g 的倍他米松二丙酸酯组成，批准用于银屑病的日常治疗，最长可达 4 周。在这里，我们描述了一项临床试验方案，用于评估每周两次使用 Cal/BD 泡沫作为斑块型银屑病的主动维持治疗长达 52 周的长期安全性和疗效。
本试验的目的是评估每周两次应用 Cal/BD 泡沫长达 52 周作为主动维持治疗的安全性和疗效，目标是尽可能长时间地预防或延迟疾病复发，同时最大限度地减少不良反应。
在初始 4 周开放标签期内，对每天一次 Cal/BD 泡沫治疗有反应的患者进行随机分组，接受每周两次 Cal/BD 泡沫或泡沫载体治疗，最长可达 52 周。在复发的情况下，两组中任何受影响的受试者都将在活跃区域接受为期 4 周的每日一次 Cal/BD 泡沫的补救治疗。因此，该试验（NCT02899962）比较了主动应用 Cal/BD 泡沫的长期使用与常规的、被动应用的方法。
疗效终点包括首次复发的时间、无复发天数和维持阶段的复发次数。安全性评估包括不良事件、反弹发生率、局部安全性和耐受性评分，以及对钙代谢和下丘脑-垂体-肾上腺轴功能的影响。
ClinicalTrials.gov 标识符，NCT02899962。
