Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Clarteis
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- repigmentation rate
研究概览
简要总结
Vitiligo is a auto immune that impact 2% of the global population, regardless from the phototype. Even though it affects patients in a physical way through loss of pigmentation, it is also impacting them on a mental/emotional way.11-12 Current treatments offer a symptomatic solution to patients, however the response rate can be low and results can be slow.
Pediatric patients in vitiligo deserves special care as frequently (50%), the disease onset is before 20 years of age and, in 25% of the cases, it starts before the age of 10 years.13 Also, the current treatments for children are limited since it can involve pain and claustrophobia. The combination therapy of the study could offer a painless and easy treatment to follow.
If the combination of those two therapies can fasten and improve the response rate, this could be a good option to treat this condition not only in children, but also for adults patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vitiligo and surface area involved of less than10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH)
- •6 weeks wash out period from previous treatments will be employed to eliminate any effect from such treatments
排除标准
- •Skin dermatoses with Kobner phenomenon
- •Lupus erythematous
- •Pacemakers
- •Hyper-photosensitivity
- •Melanoma and non-melanoma skin cancers
- •Drugs with photosensitizer side effect
- •Radiotherapy
- •Pregnancy (by principle, nno study available)
- •Diseases that are contagious by contact
研究组 & 干预措施
Tacrolimus + excimer light (group A)
group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
干预措施: exciplex (Device)
Tacrolimus + excimer light (group A)
group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
干预措施: Tacrolimus ointment (Drug)
Tacrolimus (group B)
group B will start on Tacrolimus 0.1% ointment twice daily alone
干预措施: Tacrolimus ointment (Drug)
结局指标
主要结局
repigmentation rate
时间窗: 1,2,3 and 4 months
Baseline, photos will be taken and the exact sites involved will be recorded. The clinical improvement measured by the percentage of repigmentation will be assessed and compared between the two mentioned groups at 1,2, 3 and 4 months.
次要结局
未报告次要终点