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Topical Methotrexate and CO2 Laser for Non-Segmental Vitiligo

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What is being tested

Fractional CO2 laser assisted PDT

Procedure
Who is being recruted

Pigmentation Disorders+2

+ Skin Diseases

+ Vitiligo

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2026
See protocol details

Summary

Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial explores the effectiveness of using a combination of fractional CO2 laser and topical methotrexate gel compared to using the gel alone in treating non-segmental vitiligo. The study involves adult participants aged 18-65 who have stable vitiligo with similar skin lesions on both sides of the body. This research aims to determine whether the addition of laser treatment can enhance repigmentation of the skin, providing new insights for individuals who haven’t responded to recent corticosteroid or phototherapy treatments. Such findings could lead to improved treatment options for those affected by vitiligo, potentially enhancing their quality of life. Participants in the study will have one side of their body treated with both the fractional CO2 laser and methotrexate gel, while the other side will receive only the gel, with the assignment being random to ensure unbiased results. The laser treatment is conducted in four sessions spaced three weeks apart. Throughout the six-month study, participants will undergo regular assessments including digital photography to measure skin repigmentation, safety checks, and surveys on patient satisfaction. The main goal is to see how much the skin repigments with the different treatments, while also monitoring any side effects and overall satisfaction with the treatment.

Official TitleEfficacy of Topical Methotrexate with Fractional CO2 Laser Versus Topical Methotrexate Alone in Treatment of Non Segmental Vitiligo
NCT06877455
Principal SponsorAssiut University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pigmentation DisordersSkin DiseasesVitiligoSkin and Connective Tissue DiseasesHypopigmentation

Criteria

1 inclusion criteria required to participate
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.

1 exclusion criteria prevent from participating
Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compro

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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,

Study Objectives

Primary Objectives

Study Centers

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