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NCT02104960 Clinical Trial

Study of Skin Parameters in the PROOF Cohort

Skin Aging Clinical Trial

— PEAU PROOF  

Official title:
Study of Skin Parameters in the PROOF Cohort

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02104960
Other study ID # 1308003
Secondary ID 2013-A00094-41
Status Completed
Phase N/A
First received March 28, 2014
Last updated January 13, 2015
Start date March 2013
Est. completion date December 2014

Study information
Verified date January 2015
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection AuthorityFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 209
Est. completion date December 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 75 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Dermatological clinical examination
Clinical pictures, Dermatoscopy, Elastography, Sebumetry
• Biopsy
Skin biopsy for examinations by confocal microscopy ex vivo and histopathology
• Confocal microscopy in vivo
Examination by confocal microscopy in vivo

Locations
Country Name City State
France CHU de Saint-Etienne Saint-etienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary SCINEXA score The aging of the skin is evaluated by a semi-quantitative composite of 19 clinical variables : the score SCINEXA Day 1 No
Secondary in vivo confocal microscopy Skin aging evaluated by in vivo confocal microscopy Day 1 No
Secondary ex vivo confocal microscopy 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 No
Secondary histology 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 No
Secondary RAMAN The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy Day 1 No
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