The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors

NCT ID: NCT04469582

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-01
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Bullous Pemphigoid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Associate professsor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vaia Lambadiari, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

2nd department of internal medicine,University of Athens,Greece

Evangelia Papadavid, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

2nd department of dermatology and venereology,University of Athens, Greece

Aikaterini Kountouri, MD

Role: PRINCIPAL_INVESTIGATOR

2nd department of internal medicine,University of Athens,Greece

Emmanouil Korakas, MD

Role: PRINCIPAL_INVESTIGATOR

2nd department of internal medicine,University of Athens,Greece

Sofia Theotokoglou

Role: PRINCIPAL_INVESTIGATOR

2nd department of dermatology and venereology,University of Athens, Greece

Konstantinos Theodoropoulos

Role: PRINCIPAL_INVESTIGATOR

2nd department of dermatology and venereology,University of Athens, Greece

Ignatios Ikonomidis, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

2nd department of cardiology,University of Athens,Greece

Locations

"Attikon" University General Hospital

Athens, Attica, Greece

Countries

Greece

Other Identifiers

BP-DPP4is

Identifier Type: -

Identifier Source: org_study_id