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Clinical Trials/NCT05699980
NCT05699980CompletedNot Applicable

Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation

University of Lorraine15 sites in 1 country370 target enrollmentStarted: May 23, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
370
Locations
15
Primary Endpoint
Presence or absence of dermatoporosis on the forearms or back of the hands

Study Overview

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.

Detailed Description

No clinical study has evaluated the prevalence of DP and the comorbidities often cited in adults aged 60 and over in general practice consultations.

The primary objective of this study is to assess the prevalence in a population aged 60 and over followed in a general practice in the North East of France (Lorraine). In addition, as it has been shown an association between DP and comorbidities or drug intake, the secondary objective is to investigate the possible existence of such associations.

Study design:

An observational, descriptive, transversal, multicenter study was conducted in the North East of France (Lorraine) between May and October 2022. We included by half-day, consecutively, all patients aged 60 and over presenting to a general medical consultation with 20 volunteer practitioners from the 4 Lorraine departments. Each practitioner was trained in the diagnosis of DP through a 27-minutes E-learning video and phone contacts.

Clinical and biological variables:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Refusal of participation

Outcomes

Primary Outcomes

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

Time Frame: At admission, Day 1

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

Secondary Outcomes

  • Tobacco consumption(At admission, Day 1)
  • Presence or absence of antiplatelet consumption(At admission, Day 1)
  • Presence or absence of topical corticosteroid(At admission, Day 1)
  • Childhood sun exposure(At admission, Day 1)
  • Presence or absence of chronic renal failure(At admission, Day 1)
  • Lifetime sun exposure Measurement of phototype(At admission, Day 1)
  • Presence or absence of anticoagulant consumption(At admission, Day 1)
  • Presence or absence of systemic corticosteroid therapy(At admission, Day 1)
  • Measurement of phototype(At admission, Day 1)
  • Presence or absence of diabetes(At admission, Day 1)
  • Presence or absence of inhaled corticosteroid(At admission, Day 1)

Investigators

Sponsor
University of Lorraine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antoine Truchetet

Principal investigator, MD

University of Lorraine

Study Sites (15)

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