Back to resultsEfficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Primary Purpose
Vitiligo, Pediatric ALL, Dermatologic Disease
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
exciplex
Tacrolimus ointment
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, excimer, 308nm
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
Sites / Locations
- King Abdullah University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tacrolimus + excimer light (group A)
Tacrolimus (group B)
Arm Description
group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
group B will start on Tacrolimus 0.1% ointment twice daily alone
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06035614
Brief Title
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Official Title
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarteis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Pediatric ALL, Dermatologic Disease, Autoimmune Diseases
Keywords
vitiligo, excimer, 308nm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus + excimer light (group A)
Arm Type
Active Comparator
Arm Description
group A, will be treated by Tacrolimus 0.1% ointment twice daily and excimer light 308nm twice weekly (exciplex®)
Arm Title
Tacrolimus (group B)
Arm Type
Active Comparator
Arm Description
group B will start on Tacrolimus 0.1% ointment twice daily alone
Intervention Type
Device
Intervention Name(s)
exciplex
Intervention Description
exciplex, excimer lamp 308nm produced by clarteis
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
tacrolimus monohydrate ointment 0.1% TACRUS
Primary Outcome Measure Information:
Title
repigmentation rate
Description
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.
Time Frame
1,2,3 and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
King Abdullah University Hospital
City
Ar Ramthā
ZIP/Postal Code
21410
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
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