Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache
Conditions
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
Interventions
DEVICEMethotrexate 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
Sponsors
Pharos University in Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitiligo Area and Severity Index (VASI | 2 month | in Vitiligo Area and Severity Index (VASI) from baseline to week 8 to evaluate the degree of repigmentation |
| Vitiligo Impact Scale-22 (VIS-22) | 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 |
Outcome results
None listed