- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04469582
The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors
The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Attiki
-
Athens, Attiki, Greece, 12462
- "ATTIKON" University General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline
|
Collaborators and Investigators
Sponsor
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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-DPP4is
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bullous Pemphigoid
-
Mayo ClinicEli Lilly and CompanyCompleted
-
AKARI TherapeuticsCompletedBullous Pemphigoid (BP)Germany, Netherlands
-
University Hospital, RouenNot yet recruiting
-
Peking University First HospitalWest China Hospital; Ruijin Hospital; Second Xiangya Hospital of Central South... and other collaboratorsCompleted
-
Assistance Publique Hopitaux De MarseilleUnknownBullous PemphigoidFrance
-
University Hospital, RouenSociété de Dermatologie FrançaiseUnknownBullous PemphigoidFrance
-
CHU de ReimsCompleted
-
Nihon Pharmaceutical Co., LtdCompleted
-
University of IowaGenentech, Inc.Completed
-
University Hospital, LimogesUnknownBullous PemphigoidFrance