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The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors

Sponsor
University of Athens (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04469582
Collaborator
(none)
113
Enrollment
1
Location
141
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    113 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.
    Actual Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Sep 9, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid [baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 "Attikon" University General Hospital Athens Attiki Greece 12462

    Sponsors and Collaborators

    • University of Athens

    Investigators

    • Principal Investigator: Vaia Lambadiari, MD,PhD, 2nd department of internal medicine,University of Athens,Greece
    • Principal Investigator: Evangelia Papadavid, MD,PhD, 2nd department of dermatology and venereology,University of Athens, Greece
    • Principal Investigator: Aikaterini Kountouri, MD, 2nd department of internal medicine,University of Athens,Greece
    • Principal Investigator: Emmanouil Korakas, MD, 2nd department of internal medicine,University of Athens,Greece
    • Principal Investigator: Sofia Theotokoglou, 2nd department of dermatology and venereology,University of Athens, Greece
    • Principal Investigator: Konstantinos Theodoropoulos, 2nd department of dermatology and venereology,University of Athens, Greece
    • Principal Investigator: Ignatios Ikonomidis, MD,PhD, 2nd department of cardiology,University of Athens,Greece

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ignatios Ikonomidis, Associate professsor of Cardiology, University of Athens
    ClinicalTrials.gov Identifier:
    NCT04469582
    Other Study ID Numbers:
    • BP-DPP4is
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Sep 23, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pemphigoid, Bullous

    Study Results

    No Results Posted as of Sep 23, 2020