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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

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date May 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)		 Evaluation Vitiligo [ Time Frame: At Baseline and at 6 weeks ]
Change from Baseline VES (Vitiligo Extend Score) at 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)		 Quality of life of patient [ Time Frame: At Baseline and at 6 weeks ]
Change from baseline DLQI at 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2019)		 Vitiligo activity score [ Time Frame: At baseline and at 6 months ]
Change from vaseline SA-VES (self administrated VES) at 6 months
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.
Official Title  ICMJE Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • Drug: Glisodin tablet
    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
Study Arms  ICMJE
  • Experimental: Drug
    4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
    Intervention: Drug: Glisodin tablet
  • Placebo Comparator: Placebo
    4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
    Intervention: Drug: Placebo tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2, 2020
Estimated Primary Completion Date May 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Passeron Thierry, PhD +33492034688 passeron.t@ch-nice.fr
Contact: Glenet Stéphane, Ph +33492039220 glenet.s@chu-nice.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941808
Other Study ID Numbers  ICMJE 19-PP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Passeron Thierry, PhD Centre Hospitalier Universitaire de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP