Clinical trial NCT03618277: Identification of Biomarkers and Characterization of Melasma
Official title: Identification of Biological Markers and Biometrological Characterization of Melasma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chloasma
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies
timeFrame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
measure: Change from baseline at Visite 2 : Photographic evaluation of melasma
timeFrame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
measure: Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales
timeFrame: Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Didier COUSTOU, Dr
role: PRINCIPAL_INVESTIGATOR
References: