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

Clarteis

Status: Completed

Conditions: Vitiligo; Pediatric ALL; Dermatologic Disease; Autoimmune Diseases

Treatments: Drug: Tacrolimus ointment; Device: exciplex

Study type: Interventional

Funder types: Industry

Identifiers

NCT06035614

000001112022

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Tacrolimus + excimer light (group A)

Active Comparator group

Description:

group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)

Treatment:

Drug: Tacrolimus ointment

Device: exciplex

Tacrolimus (group B)

Active Comparator group

Description:

group B will start on Tacrolimus 0.1% ointment twice daily alone

Treatment:

Drug: Tacrolimus ointment