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Identification of Biomarkers and Characterization of Melasma

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ClinicalTrials.gov Identifier: NCT03618277
Recruitment Status : Not yet recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermo Cosmetique

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.


Condition or disease Intervention/treatment Phase
Chloasma Procedure: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identification of Biological Markers and Biometrological Characterization of Melasma
Estimated Study Start Date : September 28, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Intervention Details:
  • 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.
    Other Name: Photography


Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618277


Contacts
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Contact: Sophie BARADAT + 33 5 62 87 01 78 sophie.baradat@pierre-fabre.com
Contact: Adeline BACQUEY + 33 5 62 77 53 adeline.bacquey@pierre-fabre.com

Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
Investigators
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Principal Investigator: Didier COUSTOU, Dr

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Responsible Party: Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier: NCT03618277     History of Changes
Other Study ID Numbers: MELASMAPHYSIOBIOMETRO
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases