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Topical Methotrexate with Fractional CO2 Laser in Treatment of Non Segmental Vitiligo

NCT06877455 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-14

No results posted yet for this study

Summary

This prospective, within subject clinical trial aims to evaluate the efficacy of combining fractional CO2 laser with topical methotrexate versus topical methotrexate alone in treating non-segmental vitiligo. Patients with comparable lesions on both sides of their body will receive both treatments randomly assigned to each side. The study assesses repigmentation, safety, patient satisfaction, and quality of life over six months.

Conditions

  • Vitiligo

Interventions

PROCEDURE

Fractional CO2 laser assisted PDT

One side of the body will receive fractional CO2 laser combined with methotrexate 1% gel , while the other side will receive topical methotrexate alone (or vice versa, randomized to avoid bias) for 3 months. Laser therapy will be performed as 4 sessions of 3 weeks interval using fractional ablative CO2 10,600 nm laser device (Daeshin Enterprise Co., Ltd. Model: Multixel, Seoul, Korea). A single pass will be performed at the following parameters: pulse energy 42-45 mJ, density of 100 spots/cm2 depth level of 1-2 covering an area of 1 cm2 MTX gel will be prepared in the Department of Pharmaceutics at Assiut University Patients will be followed up for total 6 months (e.g., baseline, weeks 3, 6,9,12,15 and post-treatment at months 4 and 6).

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-11-30
Completion
2026-12-30

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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 NCT06877455 on ClinicalTrials.gov