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

Not Applicable

Completed

• Conditions: Autoimmune Diseases; Pediatric ALL; Dermatologic Disease; Vitiligo
• Interventions: Drug: Tacrolimus ointment; Device: exciplex

• Registration Number: NCT06035614
• Lead Sponsor: Clarteis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-24
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus (group B)	Tacrolimus ointment	group B will start on Tacrolimus 0.1% ointment twice daily alone
Tacrolimus + excimer light (group A)	Tacrolimus ointment	group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
Tacrolimus + excimer light (group A)	exciplex	group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)

Primary Outcome Measures

Name	Time	Method
repigmentation rate	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.

Trial Locations

Locations (1)

King Abdullah University Hospital; 🇯🇴 Ar Ramthā, Jordan