NCMT Technique and Jodhpur Technique and Excimer Laser in Treatment of Non Vitiligo Leucoderma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melanocyte Keratinocyte Transplantation Procedure (MKTP), Jodhpur Technique, 308-nm Excimer Laser.
- Who it may be relevant to
- Registry conditions: Leukoderma. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Melanocyte Keratinocyte Transplantation Procedure Plus 308-nm Excimer Laser in the Treatment of Non-Vitiligo Leukoderma
Overview
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.
Interventions
- Procedure Melanocyte Keratinocyte Transplantation Procedure (MKTP)
Autologous melanocyte-keratinocyte cell suspension prepared using enzymatic separation and applied to a dermabraded recipient site. - Procedure Jodhpur Technique
Autologous non-cultured epidermal cell transfer technique using dermabraded donor skin particles applied directly to the recipient site without enzymatic processing - Device 308-nm Excimer Laser
Excimer laser therapy initiated approximately 14 days after surgery, administered twice weekly for 12-16 weeks with dose adjustment according to erythema response
Primary outcome measures
- Mean Percentage Repigmentation of Target Lesions [Time frame: 6 months]
Secondary outcome measures (2)
- Time to Onset of Repigmentation [Time frame: Up to 6 months]
- Color Match Assessment [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07662915 · RESEARCH/AZ.AST./DVA021/10/265