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business strategy
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Melasma (also called chloasma and pregnancy mask) is characterized by pigmented lesions darker than their usual complexion on the faces of affected subjects.
The physiopathology of melasma is still poorly understood. To date, the factors that favor the onset of melasma appear to be: genetic predisposing factors, changes in sex hormone levels, and sun exposure.
Vascularization as well as elastosis also appear to be increased in skin with melasma.
The aim of this study is to evaluate the different levels of expression of biomarkers between pigmented melasma lesions and surrounding healthy skin when melasma is highly pigmented but also when it is dormant (ie treated melasma, without UV solicitation in the heart of winter). The goal is to identify and better understand the involvement of different genes and proteins and thus offer more specific ways of care, and therefore effective, for the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra individual | Other | Before and after being treated by a product (outside the study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Micro-biopsies will be performed using a punch of 1 mm in diameter, by pulling the skin at the time of sampling, after disinfection and anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies | The expression levels of the biomarkers (transcriptomic and proteomic) of each zone will be measured and compared. Transcriptomic analysis will be performed by biochip. Proteomic analysis will be performed by mass spectroscopy. | Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) |
| Change from baseline at Visite 2 : Photographic evaluation of melasma | From photographs, the severity of the lesions will be evaluated. | Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) |
| Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales | Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale). | Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier COUSTOU, Dr | Principal Investigator |
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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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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D010781 | Photography |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003952 | Diagnostic Imaging |