NCT05699980

Brief Summary

The term dermatoporosis (DP) was proposed by JH. Saurat in 2004 and detailed in 2007 to describe a chronic cutaneous insufficiency and fragility syndrome. The concept of DP, the positive diagnosis and the complications are well identified in the literature. However, while the consequences of skin aging are a growing concern, knowledge of DP is stagnant. DP is clinically defined by the combination of three clinical signs: skin atrophy, white pseudo-scars, and senile purpura. It mainly sits on photo-exposed regions: posterior face of the forearms and back of the hands in 92 to 100% of cases; but also the pre-tibial, pre-sternal, and cephalic regions. DP appears at around 60 years old and can worsen with advancing age. Complications of varying severity can occur during its development: skin tears, delayed healing, infection, hematomas including dissecting hematomas that are sometimes life-threatening. DP is classified into four stages defined in 2004 and revised in 2012. The autonomy of the DP entity or its integration as a marker in multi-organ failure has not yet been determined. It is a condition on the borders of several specialties requiring good coordination between them (dermatologists, general practitioners, geriatricians, nurses, etc.) The few published epidemiological studies report a prevalence ranging from 4% to 37.5% in patients aged 50 years and over. These epidemiological data are very heterogeneous (age of recruitment, patients hospitalized or seen on an outpatient basis in consultations of different specialties, sample of the population, etc.). Among these studies, three clinical studies, two on a French hospital cohort, the other on outpatients in Dermatology in Finland, estimated the prevalence of DP between 27 and 32% in adults aged 60 years and older. In all three studies, DP was associated with advanced age, with a risk of DP up to double in patients aged 85 and older compared to younger patients. In two of these studies, a link was suggested with the status of chronic renal failure, either independently for one, or concomitant with taking anticoagulants and corticosteroids for the other. For Kluger et al., DP was also associated with the independent use of very strong local or systemic corticosteroids. For Chanca et al., an independent link between DP and tobacco consumption, taking anticoagulant treatment, and chronic recreational sun exposure has been observed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

January 17, 2023

Last Update Submit

April 27, 2023

Conditions

Keywords

skin ageingsun exposureskin tearspurpura

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of dermatoporosis on the forearms or back of the hands

    Presence or absence of dermatoporosis on the forearms or back of the hands in patients aged 60 or over in general practice

    At admission, Day 1

Secondary Outcomes (11)

  • Measurement of phototype

    At admission, Day 1

  • Childhood sun exposure

    At admission, Day 1

  • Lifetime sun exposure Measurement of phototype

    At admission, Day 1

  • Tobacco consumption

    At admission, Day 1

  • Presence or absence of diabetes

    At admission, Day 1

  • +6 more secondary outcomes

Study Arms (1)

Patient aged 60 or over presenting to their general practitioner

Patient aged 60 or over presenting to his general practitioner (among the 20 general practitioners recruited in Lorraine (eastern France))

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 60 or over presenting to their general practitioner.

You may qualify if:

  • Patient presenting to his general practitioner
  • Patient aged 60 or over

You may not qualify if:

  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Stéphanie Chevalier

Ancerville, 55170, France

Location

Wissam Al Shouaib

Basse-Ham, 57970, France

Location

Sophie LARUELLE

Bénaménil, 54450, France

Location

Sophie Delaporte

Bulgnéville, 88140, France

Location

Cédric Berbé

Cattenom, 57570, France

Location

Sandra Pacini

Hayange, 57700, France

Location

Anais Leclerc

Hettange-Grande, 57330, France

Location

Benoit Nicolas

Hettange-Grande, 57330, France

Location

Mathieu Zimmermann

Le Val-dAjol, 88340, France

Location

Mélanie Damervalle

Longuyon, 54260, France

Location

Patrick Vauthier

Longwy, 54400, France

Location

Aurelie François

Raon-l'Étape, 88110, France

Location

Jean-Louis Autissier

Thaon-les-Vosges, 88150, France

Location

Cabinet Tronville en Barrois

Tronville-en-Barrois, 55310, France

Location

Cabinet Varangéville

Varangéville, 54110, France

Location

Related Publications (4)

  • Kaya G, Saurat JH. Dermatoporosis: a chronic cutaneous insufficiency/fragility syndrome. Clinicopathological features, mechanisms, prevention and potential treatments. Dermatology. 2007;215(4):284-94. doi: 10.1159/000107621.

    PMID: 17911985BACKGROUND
  • Mengeaud V, Dautezac-Vieu C, Josse G, Vellas B, Schmitt AM. Prevalence of dermatoporosis in elderly French hospital in-patients: a cross-sectional study. Br J Dermatol. 2012 Feb;166(2):442-3. doi: 10.1111/j.1365-2133.2011.10534.x. Epub 2011 Dec 5. No abstract available.

    PMID: 21787367BACKGROUND
  • Chanca L, Fontaine J, Kerever S, Feneche Y, Forasassi C, Meaume S, Colboc H. Prevalence and risk factors of dermatoporosis in older adults in a rehabilitation hospital. J Am Geriatr Soc. 2022 Apr;70(4):1252-1256. doi: 10.1111/jgs.17618. Epub 2021 Dec 17.

    PMID: 34918778BACKGROUND
  • Kluger N, Impivaara S. Prevalence of and risk factors for dermatoporosis: a prospective observational study of dermatology outpatients in a Finnish tertiary care hospital. J Eur Acad Dermatol Venereol. 2019 Feb;33(2):447-450. doi: 10.1111/jdv.15240. Epub 2018 Oct 1.

    PMID: 30198583BACKGROUND

MeSH Terms

Conditions

Purpura

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Antoine Truchetet, MD

    University of Lorraine

    PRINCIPAL INVESTIGATOR
  • Anne Claire Bursztejn, PHD-MD

    CHU Nancy - University of Lorraine

    STUDY DIRECTOR
  • Cédric Berbé, MD

    University of Lorraine

    STUDY DIRECTOR
  • Christophe Goetz, MD

    CHR Metz-Thionville - University of Lorraine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

May 23, 2022

Primary Completion

May 23, 2022

Study Completion

October 3, 2022

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations