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Study of Skin Parameters in the PROOF Cohort (PEAU PROOF)

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ClinicalTrials.gov Identifier: NCT02104960
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

This study aims to evaluate skin aging of an homogeneous population of 77 years old patient selected among the PROOF cohort who has been continuously investigated by cardiological examination.

Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin aging will be measured by an index of clinical aging (SCINEXA) and other complementary measures such as facial photos, standard and High Definition dermoscopy, elastography, sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.


Condition or disease Intervention/treatment
Skin Aging Other: Dermatological clinical examination Other: Biopsy Other: Confocal microscopy in vivo

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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Skin Parameters in the PROOF Cohort
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Group/Cohort Intervention/treatment
PROOF
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)
Other: Dermatological clinical examination
Clinical pictures, Dermatoscopy, Elastography, Sebumetry

Other: Biopsy
Skin biopsy for examinations by confocal microscopy ex vivo and histopathology

Other: Confocal microscopy in vivo
Examination by confocal microscopy in vivo




Primary Outcome Measures :
  1. SCINEXA score [ Time Frame: Day 1 ]
    The aging of the skin is evaluated by a semi-quantitative composite of 19 clinical variables : the score SCINEXA


Secondary Outcome Measures :
  1. in vivo confocal microscopy [ Time Frame: Day 1 ]
    Skin aging evaluated by in vivo confocal microscopy

  2. ex vivo confocal microscopy [ Time Frame: Day 1 ]
    Skin aging evaluated by ex vivo confocal microscopy ( thickness of the epidermis with and without the stratum corneum, dermis thickness , number of sweat glands per unit volume).

  3. histology [ Time Frame: Day 1 ]
    Skin aging evaluated by conventional histology (thickness of the epidermis and dermis, presence and degree of elastosis , flattening of the dermo- epidermal junction)

  4. RAMAN [ Time Frame: Day 1 ]
    The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy


Biospecimen Retention:   Samples Without DNA
Skin


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
PROOF cohort (NCT00759304)
Criteria

Inclusion Criteria:

  • included in the PROOF cohort
  • Form consent signed

Exclusion Criteria:

  • Past history of surgery and / or treatment of aesthetic medicine
  • neurological disorders
  • insulin-dependent diabetes,
  • corticosteroids or retinoids (isotretinoin, ...) > 1 year

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): NCT02104960


Locations
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France
CHU de Saint-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Elisa CINOTTI, MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02104960     History of Changes
Other Study ID Numbers: 1308003
2013-A00094-41 ( Other Identifier: ANSM )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Skin Surface Microscopy
Skin Aging
PROOF
Additional relevant MeSH terms:
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Dermatologic Agents