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

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Completed
• CT.gov ID: NCT03878433
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Glisodin; Other: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Severity of melasma [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice - Dermatology	Nice	Alpes-Maritime	France	06001

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Passeron Thierry, PhD, Dermatologie, CHU de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT03878433
• Other Study ID Numbers: 18-PP-02
• First Posted: Mar 18, 2019
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanosis

Study Results

No Results Posted as of Sep 14, 2021