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临床试验/NCT04469582
NCT04469582Unknown不适用

The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.

University of Athens1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
113
试验地点
1
主要终点
Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid

研究概览

简要总结

The investigators conducted a prospective study which included all patients diagnosed with biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and December 31, 2019. 113 consecutive patients with BP were identified. The investigators included the patients with type 2 diabetes and investigated the percentage of patients who were under treatment with DPP4-is. The specific DPP4-i prescribed was also documented.Medical information including patients' age, sex, other comorbidities and concomitant medications were also recorded. Furthermore, the investigators evaluated the effect of different types of treatment (topical steroids, systemic corticosteroids, immunosuppressive agents) on bullous pemphigoid.

详细描述

Bullous pemphigoid (BP) is the most common chronic autoimmune skin disease which is characterized by the presentation of subepidermical blisters and mostly affects elderly patients . Recent studies have suggested that dipeptidyl peptidase-4 inhibitors (DPP-4is), an incretin-based drug for type 2 diabetes, as possible predisposing agents of BP . The objective of the study was to estimate the association between the use of DPP-4is and the development of BP in the setting of a tertiary university hospital and to raise awareness for everyday clinical practice, both among dermatologists as well as all physicians following patients with diabetes The study was designed as an observational prospective study.In the study included all patients who received a new diagnosis of BP and hospitalized in the Dermatology Department of our hospital between April 1, 2009 and December 31, 2019 Inclusion Criteria included a) biopsy proven bullous pemphigoid b) severe bullous pemphigoid c) recent manifestation of bullous pemphigoid (last four months).Exclusion Criteria included a) non bullous pemphigoid b) presentation of bullous pemphigoid more than four months c) treatment with DPP4is more than two years.

Overall, 113 consecutive patients with the diagnosis of BP were enrolled in the study.The investigators reviewed the percentage of patients with type 2 diabetes among all patients with BP.The number of patients who were under treatment with DPP4-is and the specific type of DPP4-is prescribed were also examined.

研究设计

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

入排标准

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

入选标准

  • biopsy proven bullous pemphigoid
  • severe bullous pemphigoid
  • recent manifestation of bullous pemphigoid (last four months)

排除标准

  • non bullous pemphigoid
  • presentation of bullous pemphigoid more than four months
  • treatment with DPP4is more than two years

结局指标

主要结局

Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid

时间窗: baseline

The investigators assessed the percentage of patients who were under treatment with DPP4-is among patients with bullous pemphigoid

次要结局

未报告次要终点

研究者

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

Ignatios Ikonomidis

Associate professsor of Cardiology

University of Athens

研究点 (1)

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