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

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

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 Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Glisodin tablet; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-Maritime
    • Nice, Alpes-Maritime, France, 06001
      • Passeron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug; 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months	Drug: Glisodin tablet; 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Placebo Comparator: Placebo; 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months	Drug: Placebo tablet; 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation Vitiligo	Change from Baseline VES (Vitiligo Extend Score) at 6 months	At Baseline and at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patient	Change from baseline DLQI at 6 months	At Baseline and at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitiligo activity score	Change from vaseline SA-VES (self administrated VES) at 6 months	At baseline and at 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Passeron Thierry, PhD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): May 2, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 19-PP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No