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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06035614
• Other study ID #: 000001112022
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: Clarteis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Dermatologic Disease
• Pediatric ALL
• Skin Diseases
• Vitiligo

Intervention

Device:
• exciplex
exciplex, excimer lamp 308nm produced by clarteis

Drug:
• Tacrolimus ointment
tacrolimus monohydrate ointment 0.1% TACRUS

Locations

Country	Name	City	State
Jordan	King Abdullah University Hospital	Ar Ramtha

Sponsors (1)

Lead Sponsor	Collaborator
Clarteis

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	repigmentation rate	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.	1,2,3 and 4 months