Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.
Vitisod
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 24, 2026
March 1, 2026
11 months
March 29, 2019
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation Vitiligo
Change from Baseline VES (Vitiligo Extend Score) at 6 months
At Baseline and at 6 weeks
Secondary Outcomes (1)
Quality of life of patient
At Baseline and at 6 weeks
Other Outcomes (1)
Vitiligo activity score
At baseline and at 6 months
Study Arms (2)
Drug
EXPERIMENTAL4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Placebo
PLACEBO COMPARATOR4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Interventions
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Eligibility Criteria
You may qualify if:
- Vitiligo
- Vitiligo, SOD, UVB
- Non-segmental vitiligo with BSA\>5%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Passeron
Nice, Alpes-Maritime, 06001, France
Related Publications (1)
Fontas E, Montaudie H, Passeron T. Oral gliadin-protected superoxide dismutase in addition to phototherapy for treating non-segmental vitiligo: A 24-week prospective randomized placebo-controlled study. J Eur Acad Dermatol Venereol. 2021 Aug;35(8):1725-1729. doi: 10.1111/jdv.17331. Epub 2021 May 13.
PMID: 33931900RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Passeron Thierry, PhD
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
May 8, 2019
Study Start
June 17, 2019
Primary Completion
May 2, 2020
Study Completion
December 1, 2020
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share