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The Value of Methotrexate in NCES for Stable Vitiligo

NCT07352293 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if adding a six months course of Methotrexate would improve the results of non cultured epidermal suspension (NCES) in adult patients with acral and resistant vitiligo lesions over the elbows and knees. researchers will compare results of NCES in two groups one group will receive Methotrexate for 3 months prior to the procedure and 3 months after the procedure, while the other group will not receive the drug. Patients will receive PUVA hand \& feet 3 times/week for 3 months after NCES during this period they will be followed up monthly to evaluate repigmentation.

Conditions

  • Vitiligo

Interventions

PROCEDURE

Non cultured epidermal suspension

Under aseptic precautions and local anesthesia, a Thiersch graft about one-third the size of the recipient area will be harvested from the donor site (usually upper thigh/ buttocks). The skin graft will be transferred to trypsin-EDTA solution and incubated at 37 °C for 20-30 minutes to separate epidermis from the dermis and then washed with PBS. The tissue will be teased gently with sterile forceps to release epidermal cells from the trypsin digested graft. The white dermis will be removed, and the suspension will be centrifuged at 1000g for 5-10 minutes and the supernatant will be discarded. Under strict asepsis, the recipient vitiliginous areas will be anesthetized followed by fractional laser CO2 resurfacing, using dot mode off resurfacing at a power of 18-20 W, dwell time 1,500-2000 milliseconds (DEKA, Florence, Italy). One to three passes will be performed until the epidermis is removed uniformly. Then, the NCES will be applied and uniformly spread.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352293 on ClinicalTrials.gov