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The differences of clinicopathological, laboratory features, and disease activity between dipeptidyl peptidase 4 inhibitors-induced bullous pemphigoid and classic bullous pemphigoid

A comparative study of clinical and laboratory characteristics and disease activity of dipeptidyl peptidase 4 (DPP4) inhibitors-induced bullous pemphigoid and classic bullous pemphigoid in type 2 diabetes mellitus patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20190605003
Enrollment
Unknown
Registered
2019-06-05
Start date
2019-03-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dipeptidyl peptidase 4 inhibitors&#45

Interventions

To assess the causal relation of DPP4i agents to BP&#44
the World Health Organization&#45
Uppsala monitoring center (WHO&#45
UMC) criteria was operated. All the patients were considered the time relationship to drug intake and must be categorized into causality terms defined as a certain&#44
probable and possible case. ,The other patients who were not defined as DPP4i&#45
related BP.
Diagnostic,Diagnostic
DPP4i&#45
induced BP in DM2 patients,Classic BP in DM2 patients (controls)

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
15 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients aged 15 years or older who were diagnosed with DM2 before the onset of BP were recruited. The diagnosis of BP was confirmed in the patients possessing at least 3 out of the 4 following criteria: clinical consistency with BP; subepidermal separation with dermal inflammatory-cell infiltrations in skin histopathology; IgG and/or C3 depositions in linear pattern along the DEJ by direct immunofluorescence (DIF) or linear IgG on the epidermal side of the skin in salt-split indirect immunofluorescence (IIF); the positive results of anti-BP180 IgG and/or anti-BP230 enzyme-linked immunosorbent assays (ELISA) in patient with equivocal DIF and IIF.

Exclusion criteria

Exclusion criteria: The patients whose diagnoses were not consistent with BP were dismissed. Sixteen patients having BP induced by other drugs apart from DPP4i agents or having incomplete records were excluded. Five patients were excluded due to conflicting relations and the remaining 16 patients were categorized as DPP4i-induced BP cases.

Design outcomes

Primary

MeasureTime frame
disease activity 6 months Bullous Pemphigoid Disease Area Index (BPDAI)—

Secondary

MeasureTime frame
clinical features 6 months Clinical features included BP patterns (localized or generalized), atypical forms of BP (serpiginous,Histopathological features 6 months eosinophilic spongiosis, presence of necrotic keratinocytes, inflammatory-cell infiltrations,laboratory results 6 months complete blood count (CBC) such as level of hemoglobin, platelets and absolute eosinophil count,Immunofluorescence (DIF/IIF) features 6 months The autoantibodies for BP180 and BP230 were measured using a commercial ELISA method.—

Contacts

Public ContactNathathai Pratumchart

Division of Dermatology, Faculty of Internal medicine, Ramathibodi Hospital, Mahidol University

nuttiejaa@gmail.com+66860771818

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026