Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
Study NCT ID:
NCT04237103
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults with Progressive Vitiligo
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults with Progressive Vitiligo: a Randomized Double-blind Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METVI
Brief 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: