Bullous pemphigoid Skin and Connective Tissue Diseases
Conditions
Interventions
The study design is a cross-sectional observational study of patients newly diagnosed with bullous pemphigoid. Patients with clinically suspected bullous pemphigoid will be referred from dermatology c
Sponsors
University Hospitals of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study. 2. Aged 18 years or above. 3. Clinical diagnosis of suspected bullous pemphigoid. 4. Direct immunofluorescence on skin biopsy (which is performed as part of usual care) demonstrating linear deposition of IgG and/or C3 at the basement membrane zone reported within 8 weeks of enrolment. 5. Able (in the Investigators’ opinion) and willing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Alternative diagnosis to bullous pemphigoid at review by a dermatologist. 2. Skin biopsy is judged to be contraindicated for clinical reasons by the Investigator. 3. Direct immunofluorescence of a skin biopsy fails to demonstrate linear deposition of IgG or C3 at the basement membrane zone within 8 weeks of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BPDAI score in two groups: patients with circulating autoantibodies to the juxtamembranous extracellular noncollagenous 16A domain (NC16A) of COL17; versus patients with circulating antibodies to Full COL17 without NC16A, measured by ELISA at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relative frequency of HLA types and prior exposure to drugs, including DPP-4 inhibitors or other drug classes known to be associated with bullous pemphigoid, in different immunophenotype groups. We will perform and compare the following tests at baseline assessment: 1.1 HLA type 1.2 Immunoblotting 1.3 Dot blotting 1.4 BP230 ELISA | — |
Countries
United Kingdom
Contacts
Public ContactMatthew Scorer
Outcome results
None listed