Melasma
Conditions
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.
Interventions
DRUGGlisodin
500 mg/day between 12 weeks
OTHERplacebo
Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
France
Outcome results
None listed