Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedSeptember 13, 2023
September 1, 2023
7 months
October 24, 2022
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Tacrolimus + excimer light (group A)
ACTIVE COMPARATORgroup A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
Tacrolimus (group B)
ACTIVE COMPARATORgroup B will start on Tacrolimus 0.1% ointment twice daily alone
Interventions
tacrolimus monohydrate ointment 0.1% TACRUS
Eligibility Criteria
You may qualify if:
- vitiligo and surface area involved of less than10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH)
- weeks wash out period from previous treatments will be employed to eliminate any effect from such treatments
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clarteislead
Study Sites (1)
King Abdullah University Hospital
Ar Ramtha, 21410, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
September 13, 2023
Study Start
October 1, 2022
Primary Completion
May 1, 2023
Study Completion
July 1, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share