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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Active Comparator | Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast |
|
| No Drug | Placebo Comparator | 2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glisodin | Drug | 500 mg/day between 12 weeks |
| |
| placebo |
| 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 Ã 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Passeron Thierry, PhD | Dermatologie, CHU de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice - Dermatology | Nice | Alpes-Maritime | 06001 | France |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Other |
Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months |
|
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 |