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

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ClinicalTrials.gov Identifier: NCT06035614

Recruitment Status : Completed

First Posted : September 13, 2023

Last Update Posted : September 13, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Clarteis

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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
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 :	October 1, 2022
Actual Primary Completion Date :	May 1, 2023
Actual Study Completion Date :	July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo

MedlinePlus related topics: Vitiligo

Drug Information available for: Tacrolimus

Genetic and Rare Diseases Information Center resources: Childhood Acute Lymphoblastic Leukemia Hypomelanotic Disorder

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

repigmentation rate [ Time Frame: 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

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Ages Eligible for Study:	4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035614

Locations

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Jordan
King Abdullah University Hospital
Ar Ramthā, Jordan, 21410

Sponsors and Collaborators

Clarteis

More Information

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Responsible Party:	Clarteis
ClinicalTrials.gov Identifier:	NCT06035614
Other Study ID Numbers:	000001112022
First Posted:	September 13, 2023 Key Record Dates
Last Update Posted:	September 13, 2023
Last Verified:	September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

Keywords provided by Clarteis:


vitiligo excimer 308nm

Additional relevant MeSH terms:

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Vitiligo Skin Diseases Autoimmune Diseases Immune System Diseases Hypopigmentation Pigmentation Disorders Tacrolimus	Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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