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

Sponsor

Clarteis (Industry)

Overall Status

Completed

CT.gov ID

NCT06035614

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo Pediatric ALL Dermatologic Disease Autoimmune Diseases	Device: exciplex Drug: Tacrolimus ointment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tacrolimus + excimer light (group A) group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)	Device: exciplex exciplex, excimer lamp 308nm produced by clarteis Drug: Tacrolimus ointment tacrolimus monohydrate ointment 0.1% TACRUS
Active Comparator: Tacrolimus (group B) group B will start on Tacrolimus 0.1% ointment twice daily alone	Drug: Tacrolimus ointment tacrolimus monohydrate ointment 0.1% TACRUS

Arm

Intervention/Treatment

Active Comparator: Tacrolimus + excimer light (group A)

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

Device: exciplex

exciplex, excimer lamp 308nm produced by clarteis

Drug: Tacrolimus ointment

tacrolimus monohydrate ointment 0.1% TACRUS

Active Comparator: Tacrolimus (group B)

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

Drug: Tacrolimus ointment

tacrolimus monohydrate ointment 0.1% TACRUS

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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