Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Percentage of repigmented surface area of the target lesion ≥75%
研究概览
简要总结
Multicentric French parallel double-blind randomized versus placebo study
详细描述
Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject male or female with age over 18 years old
- •Diagnosis of non-segmental (symmetrical) vitiligo
- •Presence of at least one vitiligo target-plaque on the face, with:
- •Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration)
- •Subject affiliated to the French social security system
排除标准
- •Progressive vitiligo over the last 3 months
- •Spontaneous ongoing repigmentation (documented in the last 3 months)
- •Previous topical Tacrolimus treatment in the last 3 months
- •Previous topical or systemic treatment in the last month:
- •Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator
- •Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments
- •Known sensitivity to study drug or macrolides
- •Past history of skin cancer or lymphoma
- •Congenital or acquired immunodeficiency
- •Pregnant or breastfeeding women
- •Women without contraception
- •Absence of signed informed consent
研究组 & 干预措施
Tacrolimus group
Target-lesion will be treated with the study treatment BID. The batch of treatment (Tacrolimus ointment 0.1% or placebo) will be randomized. All the patients will be treated during 6 months. Counselling on natural daylight exposition will also be given to all patients. During the 6-month observation period, relapse (worsening of VASI ≥ 25%) will be re-treated by the study treatment
干预措施: tacrolimus (Drug)
Control group
In the Control group, patients will receive the placebo ointment to be applied twice a day during 24 weeks.
Counselling on natural light exposure during the duration of the trial will be given.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of repigmented surface area of the target lesion ≥75%
时间窗: One year
To test the efficacy of a 24 weeks months Tacrolimus 0.1% ointment treatment vs placebo in an adult population with stable non-segmental vitiligo of the face. Therapeutic success is defined as the variation in percentage of repigmented surface area of the target lesion ≥75% at 24 weeks months.
次要结局
- Variation in percentage of repigmented surface area(48 weeks)
- Variation of patient's global satisfaction using Likert score(48 weeks)
- Variation of the Dermatology Life Quality Index(24 weeks)
- Number of participants with Adverse events(24 weeks)
- Variation of the physician global evaluation of treatment efficacy(48 weeks)