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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorPharos University in Alexandria

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Methotrexate IontophoresisExperimental treatment 1 intervention

Group B: Topical Methotrexate 1% GeActive comparator 1 intervention

Trial outcomes

Primary outcomes

Vitiligo Area and Severity Index (VASI

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

Time frame

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

Time frame

2month

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharos University in Alexandria

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: