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

NCT ID: NCT07208890

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2026-03-10

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

Detailed Description

Vitiligo is an autoimmune depigmenting disorder characterized by melanocyte destruction. Methotrexate (MTX) has shown potential in modulating autoimmune activity and promoting repigmentation, but systemic use carries hepatotoxic risks. This pilot randomized study compares methotrexate iontophoresis and topical methotrexate 1% gel in stable vitiligo patients. Thirty participants will be assigned equally into two groups: the iontophoresis group will receive MTX via low-intensity electric current sessions for 8 weeks, while the control group will apply topical MTX gel twice daily for the same period. Efficacy will be evaluated using the Vitiligo Area and Severity Index (VASI) and quality of life by the Vitiligo Impact Scale-22 (VIS-22). Liver function will be monitored monthly to ensure safety

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Methotrexate Iontophoresis

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

Group Type: EXPERIMENTAL

Methotrexate Iontophoresis/a low-intensity electric current

Intervention Type: 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

Topical Methotrexate 1% Ge

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

Group Type: ACTIVE_COMPARATOR

Methotrexate Iontophoresis/a low-intensity electric current

Intervention Type: 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

Interventions

Methotrexate Iontophoresis/a low-intensity electric current

: 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

Intervention Type: DEVICE

Other Intervention Names

: 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

Eligibility Criteria

Inclusion Criteria

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

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharos University in Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Elsayed Elgohary

Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

pharos university

Identifier Type: -

Identifier Source: org_study_id