Identification of Biomarkers and Characterization of Melasma
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|ClinicalTrials.gov Identifier: NCT03618277|
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Chloasma||Procedure: Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Identification of Biological Markers and Biometrological Characterization of Melasma|
|Estimated Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
- Procedure: Biopsy
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.Other Name: Photography
- Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies [ Time Frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) ]
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.
- Change from baseline at Visite 2 : Photographic evaluation of melasma [ Time Frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) ]From photographs, the severity of the lesions will be evaluated.
- Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales [ Time Frame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days) ]Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618277
|Contact: Sophie BARADAT||+ 33 5 62 87 01 email@example.com|
|Contact: Adeline BACQUEY||+ 33 5 62 77 firstname.lastname@example.org|
|Principal Investigator:||Didier COUSTOU, Dr|