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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
|
| Placebo | Placebo Comparator | 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glisodin tablet | Drug | 4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation Vitiligo | Change from Baseline VES (Vitiligo Extend Score) at 6 months | At Baseline and at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patient | Change from baseline DLQI at 6 months | At Baseline and at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vitiligo activity score | Change from vaseline SA-VES (self administrated VES) at 6 months | At baseline and at 6 months |
Inclusion Criteria:
Exclusion Criteria:
Criteria of non-inclusion
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| Name | Affiliation | Role |
|---|---|---|
| Passeron Thierry, PhD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Passeron | Nice | Alpes-Maritime | 06001 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33931900 | Result | 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. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo tablet |
| Drug |
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months |
|