Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06035614 |
Recruitment Status :
Completed
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
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 |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Jordan | |
King Abdullah University Hospital | |
Ar Ramthā, Jordan, 21410 |
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 |
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 |
vitiligo excimer 308nm |
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 |