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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Vitiligo

Treatments: Drug: Glisodin tablet; Drug: Placebo tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03941808

19-PP-01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Description:

4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Treatment:

Drug: Glisodin tablet

Placebo

Placebo Comparator group

Description:

4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months

Treatment:

Drug: Placebo tablet