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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Fractional CO2 laser assisted PDT

Detailed Description

The study is a prospective, within subject, self-controlled, randomized clinical trial conducted at the Department of Dermatology, Assiut University. 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. Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compromised immune function, and skin type 1 with phototherapy allergy.

Intervention and Follow-Up 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.

Outcome Measures The primary outcome is the percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists. Secondary outcomes include safety evaluation, patient satisfaction, the pattern of repigmentation, the Vitiligo Area Scoring Index (VASI) score, and quality of life measured using a validated questionnaire.

Methods for Evaluation Photographs will be taken under Wood's lamp examination at baseline, before each treatment session, and two months after the final treatment. The efficacy will be evaluated by comparing pre- and post-treatment photographs. Safety and patient satisfaction will be assessed throughout the study period. The study aims to provide evidence on the effectiveness of combining fractional CO2 laser with topical methotrexate for vitiligo treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compro

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: topical methotrexate with fractional CO2 laser versus topical methotrexate alone; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of repigmentation	percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists	6months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: vitiligo; co2 laser; fractional
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo
• Other Study ID Numbers: fractional laser for vitiligo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No