Vitiligo
Conditions
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.
Interventions
DRUGGlisodin tablet
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
DRUGPlacebo tablet
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation Vitiligo | At Baseline and at 6 weeks | Change from Baseline VES (Vitiligo Extend Score) at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life of patient | At Baseline and at 6 weeks | Change from baseline DLQI at 6 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPasseron Thierry, PhD
Centre Hospitalier Universitaire de Nice
Outcome results
None listed