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

Vitiligo Clinical Trial

— Vitisod  

Official title:

Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941808
• Other study ID #: 19-PP-01
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Glisodin tablet
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
• Placebo tablet
4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Locations

Country	Name	City	State
France	Passeron	Nice	Alpes-Maritime

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitiligo activity score	Change from vaseline SA-VES (self administrated VES) at 6 months	At baseline and at 6 months
Primary	Evaluation Vitiligo	Change from Baseline VES (Vitiligo Extend Score) at 6 months	At Baseline and at 6 weeks
Secondary	Quality of life of patient	Change from baseline DLQI at 6 months	At Baseline and at 6 weeks