Study of Skin Parameters in the PROOF Cohort

Completed

• Conditions: Skin Aging
• Interventions: Other: Dermatological clinical examination; Other: Biopsy; Other: Confocal microscopy in vivo

• Registration Number: NCT02104960
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PROOF	Biopsy	Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)
PROOF	Dermatological clinical examination	Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)
PROOF	Confocal microscopy in vivo	Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304)

Primary Outcome Measures

Name	Time	Method
SCINEXA score	Day 1	The aging of the skin is evaluated by a semi-quantitative composite of 19 clinical variables : the score SCINEXA

Secondary Outcome Measures

Name	Time	Method
ex vivo confocal microscopy	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).
histology	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)
in vivo confocal microscopy	Day 1	Skin aging evaluated by in vivo confocal microscopy
RAMAN	Day 1	The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France