- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07662915
NCMT Technique and Jodhpur Technique and Excimer Laser in Treatment of Non Vitiligo Leucoderma
June 17, 2026 updated by: Mohamed Mahmoud Mohamed Mahmoud, Al-Azhar University
Efficacy and Safety of Melanocyte Keratinocyte Transplantation Procedure Plus 308-nm Excimer Laser in the Treatment of Non-Vitiligo Leukoderma
This study aims to compare the efficacy and safety of Melanocyte Keratinocyte Transplantation Procedure (MKTP) combined with 308-nm excimer laser versus Jodhpur technique combined with 308-nm excimer laser in the treatment of stable non-vitiligo leukoderma.
Twenty-two patients with stable depigmented lesions will be enrolled.
In each patient, two comparable lesions will be treated using different techniques.
Clinical outcomes including percentage of repigmentation, color match, time to onset of repigmentation, complications, and histological changes will be assessed during follow-up to determine the optimal surgical treatment approach for non-vitiligo leukoderma.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Mahmoud
- Phone Number: +201091865997
- Email: mas912m@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 to 60 years.
- Clinically diagnosed stable non-vitiligo leukoderma.
- Stable lesion(s) for at least 6 months with no progression.
- Inadequate response to conventional medical therapy.
- Presence of two comparable lesions
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Vitiligo or suspected active vitiligo.
- History of keloid or hypertrophic scar formation.
- Active infection at donor or recipient sites.
- Bleeding disorders or anticoagulant therapy that cannot be safely discontinued.
- Pregnancy or lactation.
- Immunosuppression or uncontrolled systemic disease.
- Inability to comply with follow-up visits.
- Unrealistic expectations regarding treatment outcome.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MKTP+ excimer laser
Melanocyte Keratinocyte Transplantation Procedure followed by 308-nm excimer laser therapy
|
Autologous melanocyte-keratinocyte cell suspension prepared using enzymatic separation and applied to a dermabraded recipient site.
Excimer laser therapy initiated approximately 14 days after surgery, administered twice weekly for 12-16 weeks with dose adjustment according to erythema response
|
|
Experimental: Jodhpur Technique + Excimer Laser
Jodhpur technique followed by 308-nm excimer laser therapy
|
Excimer laser therapy initiated approximately 14 days after surgery, administered twice weekly for 12-16 weeks with dose adjustment according to erythema response
Autologous non-cultured epidermal cell transfer technique using dermabraded donor skin particles applied directly to the recipient site without enzymatic processing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Percentage Repigmentation of Target Lesions
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to Onset of Repigmentation
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Color Match Assessment
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
June 17, 2026
First Submitted That Met QC Criteria
June 17, 2026
First Posted (Actual)
June 23, 2026
Study Record Updates
Last Update Posted (Actual)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESEARCH/AZ.AST./DVA021/10/265
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukoderma
-
Chang Gung Memorial HospitalApollo Medical Optics, LtdCompleted
Clinical Trials on Melanocyte Keratinocyte Transplantation Procedure (MKTP)
-
Henry Ford Health SystemWithdrawn
-
Henry Ford Health SystemUnknownVitiligo | Depigmented Scars | DepigmentationUnited States
-
Cairo UniversityCompleted
-
Royan InstituteCompletedVitiligoIran, Islamic Republic of
-
Avita MedicalTerminated
-
Universitas PadjadjaranCompleted
-
Georgetown UniversityCompleted
-
Okayama UniversityNational Cerebral and Cardiovascular CenterCompletedHeart Failure | Hypoplastic Left Heart Syndrome | Single VentricleJapan
-
Loma Linda UniversityCompletedHeart FailureUnited States