- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104960
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-etienne, France, 42000
- Chu de Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Elisa CINOTTI, MD, Chu de Saint-Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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