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

NCT06877455 | Not Yet Recruiting

• 1 other identifier: fractional laser for vitiligo
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

fractional; co2 laser; vitiligo

Outcome Measures

Primary Outcomes (1)

• percentage of repigmentation

  percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists

  6months

Study Arms (1)

topical methotrexate with fractional CO2 laser versus topical methotrexate alone

EXPERIMENTAL

One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone,

Procedure: Fractional CO2 laser assisted PDT

Interventions

Fractional CO2 laser assisted PDT PROCEDURE

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).

topical methotrexate with fractional CO2 laser versus topical methotrexate alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Abdelmaksoud A, Dave DD, Lotti T, Vestita M. Topical methotrexate 1% gel for treatment of vitiligo: A case report and review of the literature. Dermatol Ther. 2019 Sep;32(5):e13013. doi: 10.1111/dth.13013. Epub 2019 Jul 16.

  PMID: 31265164 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of dermatology and venereology department

Model Details: One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone, with treatments randomized to avoid bias. The laser therapy consists of four sessions at three-week intervals using specific parameters. Participants will be followed up for six months, with assessments at baseline, during treatment, and post-treatment.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share