Study of Skin Parameters in the PROOF Cohort | NCT02104960

Studies
Study of Skin Parameters in the PROOF Cohort

NCT02104960

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Jan 14, 2015Estimated

Enrollment

209Actual

Phase

Not provided

Conditions

Skin Aging

Interventions

Dermatological clinical examination
Biopsy
Confocal microscopy in vivo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-A00094-41	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermatological clinical examination	Other	Clinical pictures, Dermatoscopy, Elastography, Sebumetry	PROOF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
in vivo confocal microscopy	Skin aging evaluated by in vivo confocal microscopy	Day 1
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).

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

PROOF cohort (NCT00759304)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisa CINOTTI, MD	CHU de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Saint-Etienne		Saint-Etienne		42000	France

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy
D018613	Microscopy, Confocal

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided