Clinical trial NCT05699980: Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation
Official title: Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatoporosis
Keywords: skin ageing
sun exposure
skin tears
purpura
Lead sponsor: University of Lorraine
Sponsor class: OTHER
Collaborators: name: Study Director: Anne Claire Bursztejn, PHD-MD, CHU Nancy - University of Lorraine
name: Study Chair: Christophe Goetz, MD, CHR Metz-Thionville - University of Lorraine
First posted: 2023-01-26
Enrollment: 370
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 60 or over presenting to their general practitioner.

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:

For each patient, the general practitioner performed his usual clinical examination, with a dermatological examination of the upper limbs. He completed an anonymous online questionnaire with data collected from the interrogation, medical files, and clinical examination.

The following data were reported: demographic data, active or former smoking, diabetes, dermatological history (atopic dermatitis, bullous dermatosis, psoriasis), chronic renal failure (MDRD \< 60ml /min/m2), past sun exposure, Fitzpatrick phototype, treatments (anticoagulant, antiplatelet, systemic, local, inhaled corticosteroid therapy (cumulative duration \>= 1 month)).

Finally, the signs of DP and the stage were filled in. For this study, we used the clinical staging of DP as proposed by Kaya and Saurat in 2012.

When signs of DP were present, photos of the dorsal aspect of the forearms and back of the hands (usual practice) were reviewed by the investigator and a dermatologist to confirm the diagnosis. The questionnaires were analyzed by the principal investigator.

As Chanca et al., we divided past sun exposure into three types: recreational, occupational, and childhood exposure. To assess chronic recreational sun exposure, patients were asked about past outdoor activities, such as walking or cycling at least 2 times/week. Occupational sun exposure was defined based on whether patients had an indoor or outdoor occupation. Childhood sun exposure was defined by a history of childhood sunburn.

Fitzpatrick phototype distinguishes six skin types based on tone, from very light skin that never tans (phototype 1), to dark skin, which never gets sunburn (phototype 6). According to this classification, we divided the patients into two categories: light skin (phototypes 1 to 3) and dark skin (phototypes 4 to 6).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: Presence or absence of dermatoporosis on the forearms or back of the hands
timeFrame: At admission, Day 1
Secondary outcomes:
measure: Measurement of phototype
timeFrame: At admission, Day 1
measure: Childhood sun exposure
timeFrame: At admission, Day 1
measure: Lifetime sun exposure Measurement of phototype
timeFrame: At admission, Day 1
measure: Tobacco consumption
timeFrame: At admission, Day 1
measure: Presence or absence of diabetes
timeFrame: At admission, Day 1
measure: Presence or absence of chronic renal failure
timeFrame: At admission, Day 1
measure: Presence or absence of antiplatelet consumption
timeFrame: At admission, Day 1
measure: Presence or absence of anticoagulant consumption
timeFrame: At admission, Day 1
measure: Presence or absence of systemic corticosteroid therapy
timeFrame: At admission, Day 1
measure: Presence or absence of topical corticosteroid
timeFrame: At admission, Day 1
measure: Presence or absence of inhaled corticosteroid
timeFrame: At admission, Day 1
Other outcomes:
Locations:
city: Ancerville
country: France
facility: Stéphanie Chevalier
city: Basse-Ham
country: France
facility: Wissam Al Shouaib
city: Bulgnéville
country: France
facility: Sophie Delaporte
city: Bénaménil
country: France
facility: Sophie LARUELLE
city: Cattenom
country: France
facility: Cédric Berbé
city: Hayange
country: France
facility: Sandra Pacini
city: Hettange-Grande
country: France
facility: Anais Leclerc
city: Hettange-Grande
country: France
facility: Benoit Nicolas
city: Le Val-d'Ajol
country: France
facility: Mathieu Zimmermann
city: Longuyon
country: France
facility: Mélanie Damervalle
city: Longwy
country: France
facility: Patrick Vauthier
city: Raon-l'Étape
country: France
facility: Aurelie François
city: Thaon les vosges
country: France
facility: Jean-Louis Autissier
city: Tronville-en-Barrois
country: France
facility: Cabinet Tronville en Barrois
city: Varangéville
country: France
facility: Cabinet Varangéville
Study officials:
affiliation: University of Lorraine
name: Antoine Truchetet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nancy - University of Lorraine
name: Anne Claire Bursztejn, PHD-MD
role: STUDY_DIRECTOR
affiliation: University of Lorraine
name: Cédric Berbé, MD
role: STUDY_DIRECTOR
affiliation: CHR Metz-Thionville - University of Lorraine
name: Christophe Goetz, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.