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

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

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 Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Drug: Glisodin; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-Maritime
    • Nice, Alpes-Maritime, France, 06001
      • CHU de Nice - Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug; Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast	Drug: Glisodin; 500 mg/day between 12 weeks
Placebo Comparator: No Drug; 2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo	Other: placebo; Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	At baseline and at 12 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Passeron Thierry, PhD, Dermatologie, CHU de Nice

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: 18-PP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No