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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941808
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Vitiligo Drug: Glisodin tablet Drug: Placebo tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 17, 2019
Estimated Primary Completion Date : May 2, 2020
Estimated Study Completion Date : November 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941808


Contacts
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Contact: Passeron Thierry, PhD +33492034688 passeron.t@ch-nice.fr
Contact: Glenet Stéphane, Ph +33492039220 glenet.s@chu-nice.fr

Locations
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France
Passeron Recruiting
Nice, Alpes-Maritime, France, 06001
Contact: Passeron Thierry, PhD    +33492034688    passeron.t@chu-nice.fr   
Principal Investigator: Passeron Thierry, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Passeron Thierry, PhD Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03941808    
Other Study ID Numbers: 19-PP-01
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Superoxide Dismutase
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs