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The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469582
Recruitment Status : Active, not recruiting
First Posted : July 14, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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
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.

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Study Type : Observational
Estimated 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 : April 1, 2009
Actual Primary Completion Date : September 9, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus




Primary Outcome Measures :
  1. Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid [ Time Frame: baseline ]
    The investigators assessed the percentage of patients who were under treatment with DPP4-is among patients with bullous pemphigoid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In the study included all patients diagnosed with biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and December 31, 2019.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469582


Locations
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Greece
"Attikon" University General Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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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
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Responsible Party: Ignatios Ikonomidis, Associate professsor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT04469582    
Other Study ID Numbers: BP-DPP4is
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases