Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Melasma Clinical Trial

— Glisodin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878433
• Other study ID #: 18-PP-02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Glisodin
500 mg/day between 12 weeks

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

Locations

Country	Name	City	State
France	CHU de Nice - Dermatology	Nice	Alpes-Maritime

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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