NCT07662915

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jul 2026Sep 2027

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Percentage Repigmentation of Target Lesions

    6 months

Secondary Outcomes (2)

  • Time to Onset of Repigmentation

    Up to 6 months

  • Color Match Assessment

    6 months

Study Arms (2)

MKTP+ excimer laser

EXPERIMENTAL

Melanocyte Keratinocyte Transplantation Procedure followed by 308-nm excimer laser therapy

Procedure: Melanocyte Keratinocyte Transplantation Procedure (MKTP)Device: 308-nm Excimer Laser

Jodhpur Technique + Excimer Laser

EXPERIMENTAL

Jodhpur technique followed by 308-nm excimer laser therapy

Procedure: Jodhpur TechniqueDevice: 308-nm Excimer Laser

Interventions

Autologous melanocyte-keratinocyte cell suspension prepared using enzymatic separation and applied to a dermabraded recipient site.

MKTP+ excimer laser

Autologous non-cultured epidermal cell transfer technique using dermabraded donor skin particles applied directly to the recipient site without enzymatic processing

Jodhpur Technique + 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

Jodhpur Technique + Excimer LaserMKTP+ excimer laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Mohamed Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD researcher

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

July 1, 2026

Primary Completion

July 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06