Identification of Biomarkers and Characterization of Melasma

Chloasma Clinical Trial

Official title:

Identification of Biological Markers and Biometrological Characterization of Melasma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03618277
• Other study ID #: MELASMAPHYSIOBIOMETRO
• Status: Withdrawn
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: October 10, 2018

Study information

• Verified date: August 2018
• Source: Pierre Fabre Dermo Cosmetique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chloasma
• Melanosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)