Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

NCT ID: NCT03878433

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-07-01

Brief Summary

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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

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Drug

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

Group Type ACTIVE_COMPARATOR

Glisodin

Intervention Type DRUG

500 mg/day between 12 weeks

No Drug

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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Glisodin

500 mg/day between 12 weeks

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Passeron Thierry, PhD

Role: PRINCIPAL_INVESTIGATOR

Dermatologie, CHU de Nice

Locations

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CHU de Nice - Dermatology

Nice, Alpes-Maritime, France

Site Status

Countries

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France

Other Identifiers

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18-PP-02

Identifier Type: -

Identifier Source: org_study_id

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