NCT04469582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

11.4 years

First QC Date

July 9, 2020

Last Update Submit

September 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professsor of Cardiology

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

April 1, 2009

Primary Completion

September 9, 2020

Study Completion

December 31, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations