NCT04237103

Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.

Detailed description

Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing MTX taken orally once a week + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start MTX 2 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at month 2, 4 and month 8. Phone calls to the patient will be done at month 6

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Methotrexate	oral capsules taken once a week
DRUG	Placebos	Administered identically to the experimental group

Timeline

• Start date: 2023-05-23
• Primary completion: 2025-11-04
• Completion: 2025-11-04
• First posted: 2020-01-23
• Last updated: 2026-01-22

Locations

4 sites across 1 country: France