Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. (Glisodin)

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Melasma

Treatments: Other: placebo; Drug: Glisodin

Study type: Interventional

Funder types: Other

Identifiers

NCT03878433

18-PP-02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Drug

Active Comparator group

Description:

Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast

Treatment:

Drug: Glisodin

No Drug

Placebo Comparator group

Description:

2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo

Treatment:

Other: placebo