Leukoderma
Conditions
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.
Interventions
PROCEDUREMelanocyte Keratinocyte Transplantation Procedure (MKTP)
Autologous melanocyte-keratinocyte cell suspension prepared using enzymatic separation and applied to a dermabraded recipient site.
PROCEDUREJodhpur Technique
Autologous non-cultured epidermal cell transfer technique using dermabraded donor skin particles applied directly to the recipient site without enzymatic processing
DEVICE308-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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percentage Repigmentation of Target Lesions | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to Onset of Repigmentation | Up to 6 months |
| Color Match Assessment | 6 months |
Contacts
CONTACTMohamed Mahmoud
Outcome results
None listed