NCT03878433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

January 25, 2019

Last Update Submit

September 13, 2021

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    At baseline and at 12 weeks

  • Satisfaction of the patients: VAS (Visual Analog Scale)

    At baseline and at 12 weeks

Study Arms (2)

Drug

ACTIVE COMPARATOR

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

Drug: Glisodin

No Drug

PLACEBO COMPARATOR

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

Other: placebo

Interventions

GlisodinDRUG

500 mg/day between 12 weeks

Drug
placeboOTHER

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

No Drug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed melasma in adult patient
  • signed inform consent

You may not qualify if:

  • Pregnant women
  • Other pigmentary disorder of the afce
  • Coeliac disease or allergy to gluten

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Dermatology

Nice, Alpes-Maritime, 06001, France

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Passeron Thierry, PhD

    Dermatologie, CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

March 18, 2019

Study Start

April 1, 2019

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)