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Completed

NCT Number: NCT03878433

Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Dermatology

Nice, Alpes-Maritime, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glisodin

Drug

500 mg/day between 12 weeks

Placebo

Other

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

Primary outcomes

  1. Severity of melasma

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Satisfaction of the patients: VAS (Visual Analog Scale)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study

Acronym: Glisodin

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2019
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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