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

Primary Purpose

Melasma

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Glisodin

placebo

About this trial

This is an interventional other trial for Melasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de Nice - Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug

No Drug

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT03878433

First Posted

January 25, 2019

Last Updated

September 13, 2021

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT03878433

Brief Title

Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Acronym

Glisodin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melasma

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug

Arm Type

Active Comparator

Arm Description

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

Arm Title

No Drug

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Glisodin

Intervention Description

500 mg/day between 12 weeks

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Severity of melasma

Description

Time Frame

At baseline and at 12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10)

Time Frame

At baseline and at 12 weeks

Title

Satisfaction of the patients: VAS (Visual Analog Scale)

Description

Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10)

Time Frame

At baseline and at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Passeron Thierry, PhD

Organizational Affiliation

Dermatologie, CHU de Nice

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nice - Dermatology

City

Nice

State/Province

Alpes-Maritime

ZIP/Postal Code

06001

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

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