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

NCT07208890 | Not Yet Recruiting

• 1 other identifier: pharos university
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache

Outcome Measures

Primary Outcomes (2)

• Vitiligo Area and Severity Index (VASI

  in Vitiligo Area and Severity Index (VASI) from baseline to week 8 to evaluate the degree of repigmentation

  2 month

• Vitiligo Impact Scale-22 (VIS-22)

  quality of life measured by the Vitiligo Impact Scale-22 (VIS-22), percentage of repigmentation in target lesions, and the proportion of participants achieving ≥50% repigmentatio

  2month

Study Arms (2)

Methotrexate Iontophoresis

EXPERIMENTAL

Methotrexate Iontophoresis (Experimental Group) Type: Experimental Description: Participants will receive methotrexate iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session over 8 weeks - once weekly for the first 4 weeks and then every two weeks for the next 4 weeks (total 6 sessions). Device/Intervention: Iontophoresis with methotrexate solution Goal: To enhance transdermal drug delivery and promote repigmentation with minimal systemic absorption

Device: Methotrexate Iontophoresis/a low-intensity electric current

Topical Methotrexate 1% Ge

ACTIVE COMPARATOR

Type: Active Comparator Description: Participants will apply methotrexate 1% gel topically to the affected skin areas twice daily for 8 consecutive weeks. Intervention: Topical methotrexate 1% gel Goal: To assess the efficacy and safety of topical methotrexate alone compared to iontophoretic delivery

Device: Methotrexate Iontophoresis/a low-intensity electric current

Interventions

Methotrexate Iontophoresis/a low-intensity electric current DEVICE

: Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks

Also known as: : Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks

Methotrexate Iontophoresis; Topical Methotrexate 1% Ge

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is an open-label trial; neither participants nor investigators are blinded to the assigned intervention due to the different nature of application methods (iontophoresis vs. topical gel). However, outcome assessment using VASI and VIS-22 scores will be performed by an independent dermatologist who is blinded to the treatment allocation to minimize assessment bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University

Model Details: This study follows a randomized, parallel-group design involving 30 patients with stable vitiligo. Participants are randomly assigned into two equal groups: one group receives methotrexate iontophoresis (experimental group), and the other applies topical methotrexate 1% gel (control group). Both groups are treated for 8 weeks, and outcomes are compared based on pigmentation improvement (VASI) and quality of life (VIS-22)

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: November 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: March 10, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share