Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Centre Hospitalier Universitaire de Nice40 enrolled

Overview

Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Melasma

Interventions

GlisodinDRUG

500 mg/day between 12 weeks

placeboOTHER

Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically diagnosed melasma in adult patient * signed inform consent Exclusion Criteria: * Pregnant women * Other pigmentary disorder of the afce * Use of depigmentant agent in the month before the inclusion * Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion * Coeliac disease or allergy to gluten

Locations (1)

CHU de Nice - Dermatology

Nice, Alpes-Maritime, France

Outcomes

Primary Outcomes

Severity of melasma

Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A)

Time frame: At baseline and at 12 weeks

Secondary Outcomes

Quality of life of patient: VAS (Visual Analog Scale)

Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10)

Time frame: At baseline and at 12 weeks

Satisfaction of the patients: VAS (Visual Analog Scale)

Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10)

Time frame: At baseline and at 12 weeks

Data from ClinicalTrials.gov

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