Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- Vitiligo Impact Scale-22 (VIS-22)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Methotrexate Iontophoresis/a low-intensity electric current (Device)
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
Intervention: Methotrexate Iontophoresis/a low-intensity electric current (Device)
Outcomes
Primary Outcomes
Vitiligo Impact Scale-22 (VIS-22)
Time Frame: 2month
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
Vitiligo Area and Severity Index (VASI
Time Frame: 2 month
in Vitiligo Area and Severity Index (VASI) from baseline to week 8 to evaluate the degree of repigmentation
Secondary Outcomes
No secondary outcomes reported
Investigators
Ola Mohamed Elsayed Elgohary
Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University
Pharos University in Alexandria