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

Primary Purpose

Vitiligo

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Glisodin tablet

Placebo tablet

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Passeron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation Vitiligo

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

Secondary Outcome Measures

Quality of life of patient

Change from baseline DLQI at 6 months

Full Information

NCT ID

NCT03941808

First Posted

March 29, 2019

Last Updated

August 30, 2022

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT03941808

Brief Title

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

Acronym

Vitisod

Official Title

Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

May 2, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Glisodin tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation Vitiligo

Description

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

Time Frame

At Baseline and at 6 weeks

Secondary Outcome Measure Information:

Title

Quality of life of patient

Description

Change from baseline DLQI at 6 months

Time Frame

At Baseline and at 6 weeks

Other Pre-specified Outcome Measures:

Title

Vitiligo activity score

Description

Change from vaseline SA-VES (self administrated VES) at 6 months

Time Frame

At baseline and at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Passeron Thierry, PhD

Organizational Affiliation

Centre Hospitalier Universitaire de Nice

Official's Role

Principal Investigator

Facility Information:

Facility Name

Passeron

City

Nice

State/Province

Alpes-Maritime

ZIP/Postal Code

06001

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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