Identification of Biological Markers and Biometrological Characterization of Melasma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman aged 18 to 60 years old included
- •Phototype III to IV included according to Fitzpatrick classification
- •Informed consent signature
- •Subject accepting micro-biopsies on study areas
- •Subject with melasma lesions in the face of moderate to severe intensity defined by clinical rating (Physician Global Assesment Static) allowing the realization of micro-biopsies according to the opinion of the investigator
排除标准
- •Subject having planned to stay more than 7 consecutive days in a place with a significant increase in the UV index (ski holidays, travel to the tropics, etc.)
- •Subject with pigmented facial lesions other than those related to melasma.
- •Subject having already presented cicatrization disorders
- •Subject having undergone a physical treatment (radiotherapy ...) on the face, during the last 6 months or planned during the study
- •Chemical peel, laser treatment or dermabrasion, performed on the face in the 3 months preceding the inclusion visit,
- •Application of medication containing hydroquinone or other depigmenting treatments (retinoids, topical steroids) applied to the face in the 2 months prior to the inclusion visit,
- •Applying depigmenting cosmetic products to the face within 4 weeks prior to the inclusion visit
结局指标
主要结局
Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点