Detection of anti-IgE antibodies against basement membrane zone in bullous pemphigoid: a cross-sectional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Demonstration of anti-IgE antibodies in basement membrane zone by direct immunofluorescence (DIF) microscopy
Study Overview
Brief Summary
The present cross-sectional aims to detect anti-IgE antibodies against BMZ in patients with bullous pemphigoid
The primary objective of the study is to demonstrate anti-IgE antibodies in the basement membrane zone by direct immunofluorescence (DIF) microscopy in patients with bullous pemphigoid
The secondary objectives of the study are:
To demonstrate:
• The correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations, and duration of the disease)
• Bullous pemphigoid disease area index (BPDAI) score
• Association between anti-BMZ IgE antibodies in skin biopsy with eosinophil and basophil count in the peripheral blood and serum IgE and IgG (against BP180 and BP230), if done
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with a clinical diagnosis consistent with bullous pemphigoid as per the standard diagnostic criteria.
- •Direct immunofluorescence (DIF) microscopy showing linear deposits of IgG and/or Complement C3 along the basement membrane zone.
- •Indirect immunofluorescence (IIF) of salt-split skin biopsy showing deposition of IgG along the basement membrane zone, if done.
Exclusion Criteria
- •Severe bleeding and coagulation disorders.
- •Failure to obtain written informed consent for skin biopsy.
- •Severely immunosuppressed conditions, including acquired immunodeficiency syndrome (AIDS).
Outcomes
Primary Outcomes
Demonstration of anti-IgE antibodies in basement membrane zone by direct immunofluorescence (DIF) microscopy
Time Frame: During hospital stay or on OPD basis
Secondary Outcomes
- • Correlation of anti-BMZ IgE antibodies in skin biopsy with patient characteristics (age, gender, clinical manifestations and duration of the disease)(• Bullous pemphigoid disease area index (BPDAI) score)
Investigators
Saurodeep Basu
Kasturba Medical College Manipal