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临床试验/NCT05699980
NCT05699980已完成不适用

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

University of Lorraine15 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
370
试验地点
15
主要终点
Presence or absence of dermatoporosis on the forearms or back of the hands

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Refusal of participation

结局指标

主要结局

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

时间窗: 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

次要结局

  • 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)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoine Truchetet

Principal investigator, MD

University of Lorraine

研究点 (15)

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