Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methotrexate Iontophoresis/a low-intensity electric current.
- Who it may be relevant to
- Registry conditions: Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device 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
Primary outcome measures
- Vitiligo Area and Severity Index (VASI [Time frame: 2 month]
- Vitiligo Impact Scale-22 (VIS-22) [Time frame: 2month]
Eligibility criteria
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07208890 · pharos university