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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03941808

Recruitment Status Active, not recruiting

First Posted May 8, 2019

Last update posted October 30, 2020

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.

  • Condition or Disease:Vitiligo
  • Intervention/Treatment: Drug: Glisodin tablet
    Drug: Placebo tablet
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: May 2020
  • Actual Study Completion Date: December 2020
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. Evaluation Vitiligo [ Time Frame: At Baseline and at 6 weeks ]
    Change from Baseline VES (Vitiligo Extend Score) at 6 months
  • Secondary Outcome Measures: 1. Quality of life of patient [ Time Frame: At Baseline and at 6 weeks ]
    Change from baseline DLQI at 6 months
  • Other Outcome Measures: 1. Vitiligo activity score [ Time Frame: At baseline and at 6 months ]
    Change from vaseline SA-VES (self administrated VES) at 6 months
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

France, Alpes-Maritime
Passeron
Nice

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

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

More Information
  • Responsible Party: Centre Hospitalier Universitaire de Nice
  • ClinicalTrials.gov Identifier: NCT03941808 History of Changes
  • Other Study ID Numbers: 19-PP-01
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: October 30, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Vitiligo