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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06035614

Enrollment

Registered

2023-09-13

Start date

2022-10-01

Completion date

2023-07-01

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Dermatologic Disease, Pediatric ALL, Vitiligo

Keywords

vitiligo, excimer, 308nm

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.

Interventions

DEVICEexciplex

exciplex, excimer lamp 308nm produced by clarteis

DRUGTacrolimus ointment

tacrolimus monohydrate ointment 0.1% TACRUS

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026