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

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Drug: Glisodin tablet; Drug: Placebo tablet

• Registration Number: NCT03941808
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Study Start: 2019-06-17
• Primary Completion: 2020-05-02
• Status Verified: 2020-10
• Study Completion: 2020-12-01
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Vitiligo
• Vitiligo, SOD, UVB
• Non-segmental vitiligo with BSA>5%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	Glisodin tablet	4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Placebo	Placebo tablet	4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Primary Outcome Measures

Name	Time	Method
Evaluation Vitiligo	At Baseline and at 6 weeks	Change from Baseline VES (Vitiligo Extend Score) at 6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life of patient	At Baseline and at 6 weeks	Change from baseline DLQI at 6 months

Trial Locations

Locations (1)

Passeron; 🇫🇷 Nice, Alpes-Maritime, France