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Identification of Biomarkers and Characterization of Melasma

Primary Purpose

Chloasma

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Biopsy

About this trial

This is an interventional basic science trial for Chloasma

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intra individual

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Change from baseline at Visite 2 : Photographic evaluation of melasma

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

Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale).

Secondary Outcome Measures

Full Information

NCT ID

NCT03618277

First Posted

July 26, 2018

Last Updated

January 17, 2020

Sponsor

Pierre Fabre Dermo Cosmetique

1. Study Identification

Unique Protocol Identification Number

NCT03618277

Brief Title

Identification of Biomarkers and Characterization of Melasma

Official Title

Identification of Biological Markers and Biometrological Characterization of Melasma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Withdrawn

Why Stopped

business strategy

Study Start Date

October 10, 2018 (Actual)

Primary Completion Date

October 10, 2018 (Actual)

Study Completion Date

October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Dermo Cosmetique

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chloasma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intra individual

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Other Intervention Name(s)

Photography

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline at Visite 2 : Biomarkers evaluation of melasma, obtained by microbiopsies

Description

Time Frame

Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)

Title

Change from baseline at Visite 2 : Photographic evaluation of melasma

Description

From photographs, the severity of the lesions will be evaluated.

Time Frame

Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)

Title

Change from baseline at Visite 2 : Clinical evaluation of melasma by P.G.A. scales

Description

Different intensities of melasma will be evaluated by clinical rating : Physician Global Assessment (PGA) Static (4-point scale) and Dynamic (7-point scale).

Time Frame

Visit 1 (Baseline) and Visit 2 (Day 150 +/- 30 days)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier COUSTOU, Dr

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Identification of Biomarkers and Characterization of Melasma

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