Not Yet RecruitingNot Applicable

Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients

30 participantsStarted 2025-11-10

Plain-language summary

Vitiligo is a common autoimmune depigmenting disorder characterized by selective destruction of melanocytes. Methotrexate (MTX) has shown potential in stabilizing disease activity and promoting repigmentation; however, systemic administration may cause hepatotoxicity. This pilot study aims to compare the efficacy and safety of methotrexate iontophoresis versus topical methotrexate 1% gel in patients with vitiligo. Thirty patients will be randomly assigned into two equal groups: Group A will receive methotrexate iontophoresis (5-10 mA, 15 min/session) for 8 weeks, while Group B will apply methotrexate 1% gel twice daily for 8 weeks. Outcomes will be assessed using the Vitiligo Area and Severity Index (VASI) and the Vitiligo Impact Scale-22 (VIS-22), with liver function monitored monthly

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Clinically diagnosed vitiligo confirmed by a dermatologist. Stable vitiligo for at least 6 months (no new lesions or progression). Age between 18 and 60 years. Both male and female patients. Presence of localized or segmental vitiligo suitable for topical treatment. Willingness to avoid other vitiligo treatments (e.g., phototherapy, corticosteroids) during the study period. Able and willing to provide written informed consent and comply with study procedures - Exclusion Criteria:History of systemic or topical methotrexate use within the past 3 months. Unstable or rapidly progressive vitiligo during the last 6 months. Presence of other autoimmune or dermatologic disorders that could interfere with study evaluation (e.g., psoriasis, eczema, lupus). Known hypersensitivity or allergy to methotrexate or any gel/iontophoresis components. Hepatic, renal, or hematologic impairment (abnormal liver function or renal profile). Pregnant or breastfeeding women, or those planning pregnancy during the study period. Use of phototherapy, corticosteroids, or immunosuppressive therapy within the last 3 months. Metal implants or pacemakers, which may contraindicate iontophoresis \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vitiligo Area and Severity Index (VASI

Timeframe: 2 month

Vitiligo Impact Scale-22 (VIS-22)

Timeframe: 2month

Trial details

NCT IDNCT07208890

SponsorPharos University in Alexandria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-10

View on ClinicalTrials.gov More Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache trials