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| Name | Class |
|---|---|
| BIODERMA | UNKNOWN |
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Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.
40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).
There will be 3 visits: Baseline, T2.5months and T5months (final visit).
Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.
Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teinted sunscream | Experimental | UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator) |
|
| Regular sunscream | Active Comparator | UVA and UVB protection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscream with visible light protection | Other |
| ||
| Sunscream |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between MASI scores before prevention treatment and after 6 months | MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|