Prevalence and Comorbidities of Dermatoporosis: a French Prospective Observational Study in General Medicine Consultation
NCT ID: NCT05699980
Last Updated: 2023-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
370 participants
OBSERVATIONAL
2022-05-23
2022-10-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevalence and Risk Factors of Dermatoporosis in Patients Over 75 Years of Age Hospitalized in Reeducation
NCT05092204
Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up
NCT02892188
General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly
NCT03402958
Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.
NCT02861989
Association Between Dermatoporosis and Fractural Risk
NCT03998228
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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))
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient aged 60 or over
Exclusion Criteria
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Study Director: Anne Claire Bursztejn, PHD-MD, CHU Nancy - University of Lorraine
UNKNOWN
Study Chair: Christophe Goetz, MD, CHR Metz-Thionville - University of Lorraine
UNKNOWN
University of Lorraine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antoine Truchetet
Principal investigator, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antoine Truchetet, MD
Role: PRINCIPAL_INVESTIGATOR
University of Lorraine
Anne Claire Bursztejn, PHD-MD
Role: STUDY_DIRECTOR
CHU Nancy - University of Lorraine
Cédric Berbé, MD
Role: STUDY_DIRECTOR
University of Lorraine
Christophe Goetz, MD
Role: STUDY_CHAIR
CHR Metz-Thionville - University of Lorraine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stéphanie Chevalier
Ancerville, , France
Wissam Al Shouaib
Basse-Ham, , France
Sophie LARUELLE
Bénaménil, , France
Sophie Delaporte
Bulgnéville, , France
Cédric Berbé
Cattenom, , France
Sandra Pacini
Hayange, , France
Anais Leclerc
Hettange-Grande, , France
Benoit Nicolas
Hettange-Grande, , France
Mathieu Zimmermann
Le Val-dAjol, , France
Mélanie Damervalle
Longuyon, , France
Patrick Vauthier
Longwy, , France
Aurelie François
Raon-l'Étape, , France
Jean-Louis Autissier
Thaon-les-Vosges, , France
Cabinet Tronville en Barrois
Tronville-en-Barrois, , France
Cabinet Varangéville
Varangéville, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
University of Lorraine
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.