Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin disorders, Hôpital Saint-André, Bordeaux, France; INSERM U1035, Biotherapy of Genetic Diseases, Inflammatory Disorders and Cancers (BMGIC), Université de Bordeaux, Bordeaux, France.
Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin disorders, Hôpital Saint-André, Bordeaux, France.
J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.
Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use.
This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo.
This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.
Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months.
Patients received either tacrolimus 0.1% ointment or vehicle twice daily.
The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians' global assessment scores and patients' satisfaction scores, safety data, and the rate of relapse at week 48.
A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks.
Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo.
This study was registered at ClinicalTrials.gov (identifier: NCT02466997).
钙调磷酸酶抑制剂在治疗白癜风方面被超适应证使用，但是缺乏安慰剂对照、盲法研究来支持其使用。
本研究旨在比较他克莫司 0.1%软膏与赋形剂在治疗成年面部白癜风患者色素再生方面的疗效。
这是一项为期 24 周的多中心随机平行双盲研究，并有 24 周的治疗后随访扩展期。
纳入的参与者为面部白癜风新发病灶（<2 年）的成年患者，在过去 3 个月内无色素变化或大小变化。
患者接受他克莫司 0.1%软膏或赋形剂每日两次治疗。
主要结局是治疗成功，定义为在基线至 24 周时，目标病变的色素再生变化≥75%，用 ImageJ 软件测量。次要结局测量指标包括医生整体评估评分和患者满意度评分的变化、安全性数据以及第 48 周时的复发率。
共纳入 42 例患者。在第 24 周时，他克莫司治疗组有 65%的患者达到治疗成功，而赋形剂治疗组则为 0%（P<0.0001）。仅 40%的患者在 48 周时复发。
在 24 周的干预和 24 周的随访中，每日两次他克莫司 0.1%软膏在成年面部白癜风患者中显示出优于赋形剂的疗效。
本研究在 ClinicalTrials.gov 注册（标识符：NCT02466997）。
