Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Other: placebo; Drug: Glisodin

• Registration Number: NCT03878433
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2019-04-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinically diagnosed melasma in adult patient
• signed inform consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Drug	placebo	2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo
Drug	Glisodin	Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast

Primary Outcome Measures

Name	Time	Method
Severity of melasma	At baseline and at 12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Satisfaction of the patients: VAS (Visual Analog Scale)	At baseline and at 12 weeks	Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10)
Quality of life of patient: VAS (Visual Analog Scale)	At baseline and at 12 weeks	Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10)

Trial Locations

Locations (1)

CHU de Nice - Dermatology; 🇫🇷 Nice, Alpes-Maritime, France