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

NCT ID: NCT03941808

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Drug

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

Group Type EXPERIMENTAL

Glisodin tablet

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

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

Interventions

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Glisodin tablet

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

Intervention Type DRUG

Placebo tablet

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Passeron

Nice, Alpes-Maritime, France

Site Status

Countries

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France

Other Identifiers

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19-PP-01

Identifier Type: -

Identifier Source: org_study_id

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