Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children

Conditions
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Vitiligo, Pediatric ALL, Dermatologic Disease, Autoimmune Diseases

Intervention / Treatment
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* Device: exciplex
* Drug: Tacrolimus ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus + excimer light (group A)<br>group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®) | Device: exciplex<br>* exciplex, excimer lamp 308nm produced by clarteis<br>Drug: Tacrolimus ointment<br>* tacrolimus monohydrate ointment 0.1% TACRUS<br>|
| Active Comparator: Tacrolimus (group B)<br>group B will start on Tacrolimus 0.1% ointment twice daily alone | Drug: Tacrolimus ointment<br>* tacrolimus monohydrate ointment 0.1% TACRUS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repigmentation rate | 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. | 1,2,3 and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitiligo, excimer, 308nm