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

NCT ID: NCT06035614

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-07-01

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.

Conditions

Vitiligo; Pediatric ALL; Dermatologic Disease; Autoimmune Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus + excimer light (group A)

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

Group Type: ACTIVE_COMPARATOR

exciplex

Intervention Type: DEVICE

exciplex, excimer lamp 308nm produced by clarteis

Tacrolimus ointment

Intervention Type: DRUG

tacrolimus monohydrate ointment 0.1% TACRUS

Tacrolimus (group B)

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

Group Type: ACTIVE_COMPARATOR

Tacrolimus ointment

Intervention Type: DRUG

tacrolimus monohydrate ointment 0.1% TACRUS

Interventions

exciplex

exciplex, excimer lamp 308nm produced by clarteis

Intervention Type: DEVICE

Tacrolimus ointment

tacrolimus monohydrate ointment 0.1% TACRUS

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clarteis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King Abdullah University Hospital

Ar Ramtha, , Jordan

Countries

Jordan

Other Identifiers

000001112022

Identifier Type: -

Identifier Source: org_study_id