Skin AgingPEAU PROOFNCT02104960
Study of Skin Parameters in the PROOF Cohort
An observational study of Skin Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Dermatological clinical examination, Biopsy and Confocal microscopy in vivo
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: PROOF cohort (NCT00759304)
Who may be able to join
- included in the PROOF cohort
- Form consent signed
Who cannot join
- Past history of surgery and / or treatment of aesthetic medicine
- neurological disorders
- insulin-dependent diabetes,
- corticosteroids or retinoids (isotretinoin, ...) > 1 year
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Skin Aging
- Being tested
- Dermatological clinical examination, Biopsy, Confocal microscopy in vivo
- Keywords
- Skin Surface Microscopy, Skin Aging, PROOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatological clinical examinationOther
Clinical pictures, Dermatoscopy, Elastography, Sebumetry
BiopsyOther
Skin biopsy for examinations by confocal microscopy ex vivo and histopathology
Confocal microscopy in vivoOther
Examination by confocal microscopy in vivo
| Study group | Role | What they receive |
|---|---|---|
| PROOF | Healthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304) Receives: Other: Dermatological clinical examination; Other: Biopsy; Other: Confocal microscopy in vivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCINEXA score
The aging of the skin is evaluated by a semi-quantitative composite of 19 clinical variables : the score SCINEXA
Measured: Day 1
Secondary outcomes (4)
in vivo confocal microscopy
Skin aging evaluated by in vivo confocal microscopy
Measured: 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).
Measured: Day 1
histology
Skin aging evaluated by conventional histology (thickness of the epidermis and dermis, presence and degree of elastosis , flattening of the dermo- epidermal junction)
Measured: Day 1
RAMAN
The composition of subcutaneous fat measured by ex vivo RAMAN spectroscopy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa CINOTTI, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104960
- Sponsor's protocol ID
- 1308003
- Other IDs
- 2013-A00094-41
- Acronym
- PEAU PROOF
- Status last verified
- Jan 2015
- First submitted
- 28 Mar 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Skin Parameters in the PROOF Cohort
- ClinicalTrials.gov ID
- NCT02104960
- Acronym / sponsor ID
- PEAU PROOF / 1308003
- Conditions
- Skin Aging
- Keywords
- Skin Surface Microscopy, Skin Aging, PROOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROOF | – | Other: Dermatological clinical examination, Other: Biopsy, Other: Confocal microscopy in vivoHealthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date. (NCT00759304) |
Who may qualify
- Ages
- 75 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- PROOF cohort (NCT00759304)
Key inclusion criteria (2 listed)
- included in the PROOF cohort
- Form consent signed
Key exclusion criteria (4 listed)
- Past history of surgery and / or treatment of aesthetic medicine
- neurological disorders
- insulin-dependent diabetes,
- corticosteroids or retinoids (isotretinoin, ...) > 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermatological clinical examinationClinical pictures, Dermatoscopy, Elastography, Sebumetry | Other | PROOF |
| BiopsySkin biopsy for examinations by confocal microscopy ex vivo and histopathology | Other | PROOF |
| Confocal microscopy in vivoExamination by confocal microscopy in vivo | Other | PROOF |
Primary outcome
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
4 secondary outcomes
in vivo confocal microscopy
Time frame: Day 1
ex vivo confocal microscopy
Time frame: Day 1
histology
Time frame: Day 1
RAMAN
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa CINOTTI, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCINEXA score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.