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Completed

NCT Number: NCT02104960

Study of Skin Parameters in the PROOF Cohort

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.

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Key information

Conditions

Skin Aging

Age range

75 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermatological clinical examination

Other

Clinical pictures, Dermatoscopy, Elastography, Sebumetry

Biopsy

Other

Skin biopsy for examinations by confocal microscopy ex vivo and histopathology

Confocal microscopy in vivo

Other

Examination by confocal microscopy in vivo

Primary outcomes

  1. 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

Secondary outcomes

  1. in vivo confocal microscopy

    Time frame: Day 1

    Skin aging evaluated by in vivo confocal microscopy

  2. 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).

  3. 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)

  4. RAMAN

    Time frame: Day 1

    The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PEAU PROOF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2014
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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