Identification of Biomarkers and Characterization of Melasma

NCT03618277 | Withdrawn

• 1 other identifier: MELASMAPHYSIOBIOMETRO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chloasma

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Intra individual

OTHER

Before and after being treated by a product (outside the study)

Procedure: Biopsy

Interventions

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.

Also known as: Photography

Intra individual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

MeSH Terms

Conditions

Melanosis

Interventions

Biopsy; Photography

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Imaging

Study Officials

• Didier COUSTOU, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 7, 2018
• Study Start: October 10, 2018
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: January 22, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share