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OpenTrials
Completed

NCT Number: NCT03941808

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

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Passeron

Nice, Alpes-Maritime, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glisodin tablet

Drug

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

Placebo Tablet

Drug

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

Primary outcomes

  1. Evaluation Vitiligo

    Time frame: At Baseline and at 6 weeks

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

Secondary outcomes

  1. Quality of life of patient

    Time frame: At Baseline and at 6 weeks

    Change from baseline DLQI at 6 months

Other outcomes

  1. Vitiligo activity score

    Time frame: At baseline and at 6 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: Vitisod

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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