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NCT06035614 Clinical Trial

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

Autoimmune Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06035614
Other study ID # 000001112022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date July 1, 2023

Study information
Verified date September 2023
Source Clarteis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• exciplex
exciplex, excimer lamp 308nm produced by clarteis
Drug:
• Tacrolimus ointment
tacrolimus monohydrate ointment 0.1% TACRUS

Locations
Country Name City State
Jordan King Abdullah University Hospital Ar Ramtha

Sponsors (1)
Lead Sponsor Collaborator
Clarteis

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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