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

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.

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Key information

Conditions

Vitiligo Autoimmune Diseases Dermatologic Disease Hematologic Diseases Hemic and Lymphatic Diseases Hypopigmentation Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Pigmentation Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Skin Diseases Skin and Connective Tissue Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdullah University Hospital

Ar Ramtha, 21410, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exciplex

Device

exciplex, excimer lamp 308nm produced by clarteis

Tacrolimus ointment

Drug

tacrolimus monohydrate ointment 0.1% TACRUS

Primary outcomes

repigmentation rate

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clarteis

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 13, 2023
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed