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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-etienne, France, 42000
        • Chu de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PROOF cohort (NCT00759304)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PROOF
Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)
Clinical pictures, Dermatoscopy, Elastography, Sebumetry
Skin biopsy for examinations by confocal microscopy ex vivo and histopathology
Examination by confocal microscopy in vivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in vivo confocal microscopy
Time Frame: Day 1
Skin aging evaluated by in vivo confocal microscopy
Day 1
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).
Day 1
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)
Day 1
RAMAN
Time Frame: Day 1
The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elisa CINOTTI, MD, Chu de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308003
  • 2013-A00094-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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