- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618277
Identification of Biomarkers and Characterization of Melasma
Identification of Biological Markers and Biometrological Characterization of Melasma
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.
Study Overview
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intra individual
Before and after being treated by a product (outside the study)
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
|
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.
|
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
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).
|
Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Didier COUSTOU, Dr
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MELASMAPHYSIOBIOMETRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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