Bullous PemphigoidNCT04469582
The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors
An observational study of Bullous Pemphigoid, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- How many people
- 113 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2009to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- biopsy proven bullous pemphigoid
- severe bullous pemphigoid
- recent manifestation of bullous pemphigoid (last four months)
Who cannot join
- non bullous pemphigoid
- presentation of bullous pemphigoid more than four months
- treatment with DPP4is more than two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.
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.
Read the 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
- Medical subject headings
- Pemphigoid, Bullous
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Apr 2009
- Primary completion9 Sep 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Vaia Lambadiari, MD,PhD, Principal investigator, 2nd department of internal medicine,University of Athens,GreeceEvangelia Papadavid, MD,PhD, Principal investigator, 2nd department of dermatology and venereology,University of Athens, GreeceAikaterini Kountouri, MD, Principal investigator, 2nd department of internal medicine,University of Athens,GreeceEmmanouil Korakas, MD, Principal investigator, 2nd department of internal medicine,University of Athens,GreeceSofia Theotokoglou, Principal investigator, 2nd department of dermatology and venereology,University of Athens, GreeceKonstantinos Theodoropoulos, Principal investigator, 2nd department of dermatology and venereology,University of Athens, GreeceIgnatios Ikonomidis, MD,PhD, Principal investigator, 2nd department of cardiology,University of Athens,Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469582
- Sponsor's protocol ID
- BP-DPP4is
- Status last verified
- Sep 2020
- First submitted
- 9 Jul 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT04469582
- Acronym / sponsor ID
- BP-DPP4is
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- biopsy proven bullous pemphigoid
- severe bullous pemphigoid
- recent manifestation of bullous pemphigoid (last four months)
Key exclusion criteria (3 listed)
- non bullous pemphigoid
- presentation of bullous pemphigoid more than four months
- treatment with DPP4is more than two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
Related trials for Bullous Pemphigoid
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Subconjunctival Humira for Boston Keratoprosthesis
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RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
Bullous Pemphigoid (BP)
Active, not recruitingPhase 3
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
Severe Forms of Mucous Membrane Pemphigoid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vaia Lambadiari, MD,PhD principal investigator
2nd department of internal medicine,University of Athens,Greece
Evangelia Papadavid, MD,PhD principal investigator
2nd department of dermatology and venereology,University of Athens, Greece
Aikaterini Kountouri, MD principal investigator
2nd department of internal medicine,University of Athens,Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.