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

• ClinicalTrials.gov Identifier: NCT03941808
• Recruitment Status: Completed
• First Posted: May 8, 2019
• Last Update Posted: August 31, 2022
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Tracking Information

• First Submitted Date: March 29, 2019
• First Posted Date: May 8, 2019
• Last Update Posted Date: August 31, 2022
• Actual Study Start Date: June 17, 2019
• Actual Primary Completion Date: May 2, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Vitiligo

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2019): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 1, 2020
• Actual Primary Completion Date: May 2, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03941808
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Centre Hospitalier Universitaire de Nice
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Nice
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Centre Hospitalier Universitaire de Nice
• Verification Date: October 2020