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

Who is this study for? Patients with Vitiligo
What treatments are being studied? Methotrexate
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject male or female age over 18 years old

• Diagnosis of non-segmental (symmetrical) vitiligo with body surface area ≥10%

• Active non-segmental vitiligo defined by Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination.

• Signed informed consent document

• Male patients agreeing to use a reliable method of birth control during the study i. e. preservative and for at least 6 months following the last dose of investigational product, the patient's partner treated by methotrexate must be notified of the teratogenic risk of methotrexate and should be under effective contraception throughout the study and for at least 6 months following the last dose of investigational product.

• Women of childbearing potential who are negatively tested for pregnancy and agree to use a reliable method of birth control (every month) or remain abstinent during the study and for at least 6 months following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring

• Patient registered to the French Social Security

Locations
Other Locations
France
Service de Dermatologie - Hôpital Saint-André
RECRUITING
Bordeaux
Centre Hospitalier de Pau
RECRUITING
Pau
Centre Hospitalier de Périgueux
RECRUITING
Périgueux
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
RECRUITING
Toulouse
Contact Information
Primary
Julien SENESCHAL, MD, PhD
julien.seneschal@chu-bordeaux.fr
+335 56 79 49 63
Backup
Sitraka RASOLOFO
sitraka.rasolofo@chu-bordeaux.fr
+335.56.82.06.55
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2025-10-10
Participants
Target number of participants: 45
Treatments
Experimental: methotrexate
Methotrexate once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months after Methotrexate therapy for 6 months.
Placebo_comparator: placebo
Placebo once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months afterplacebo therapy, for 6 months.
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

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