Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.

Centre Hospitalier Universitaire de Nice50 enrolled

Overview

The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo. Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included. The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vitiligo

Interventions

Glisodin tabletDRUG

4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Placebo tabletDRUG

4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Vitiligo * Vitiligo, SOD, UVB * Non-segmental vitiligo with BSA\>5% Exclusion Criteria: * Criteria of non-inclusion * Segmental or mixed vitiligo * Pregnancy * Vitiligo lesions localized only on hands and feet * Immuno-suppressive drugs * Corticosteroids * Photosensitive drugs * Photodermatosis * Personal history of skin cancer * Allergy to gluten

Locations (1)

Passeron

Nice, Alpes-Maritime, France

Outcomes

Primary Outcomes

Evaluation Vitiligo

Change from Baseline VES (Vitiligo Extend Score) at 6 months

Time frame: At Baseline and at 6 weeks

Secondary Outcomes

Quality of life of patient

Change from baseline DLQI at 6 months

Time frame: At Baseline and at 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.