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Comparing Different Laboratory Tests to Diagnose Autoimmune Blistering Skin Diseases A Pilot Study

To Compare the Utility of Immunofluorescence Techniques [Direct and Indirect Immunofluorescence with Salt-Split Skin Assay], Biochip Mosaic Assay, and Multiplex ELISA in the Diagnosis of Autoimmune Bullous Diseases A Prospective Cross-Sectional Pilot Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084468
Enrollment
85
Registered
2025-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: L14- Bullous disorders in diseases classified elsewhere Health Condition 2: L11- Other acantholytic disorders Health Condition 3: L13- Other bullous disorders Health Condition 4: L12- Pemphigoid Health Condition 5: L10- Pemphigus

Interventions

Intervention1: NIL: NIL

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Active cases of autoimmune bullous diseases (AIBDs), both intraepidermal and subepidermal, of any age and gender, diagnosed on the basis of clinical features, histopathological examination and Immunoblot assay (for detection of specific antigens). 2.Patients giving consent for participation in the study and obtaining skin biopsy (lesional and perilesional normal skin) and venous blood samples.

Exclusion criteria

Exclusion criteria: 1.Patients of AIBDs with inactive disease. 2.Patients who are on oral immunosuppressive therapy other than oral corticosteroids (=20mg/day) for past 4 weeks or have received rituximab in past 6 months. 3.Patients who are transplant recipients or on chemotherapy, or any major immunosuppression. 4.Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
To assess the utility of immunofluorescence (IF) techniques (direct immunofluorescence, indirect immunofluorescence with salt-split skin assay) in the diagnosis of autoimmune bullous diseases (AIBDs)Timepoint: Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

Secondary

MeasureTime frame
Comparison of IF techniques with Biochip mosaic assay & Multiplex ELISA (Dermatology Profile ELISA) in the diagnosis of AIBDsTimepoint: Baseline Data will be collected & will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month

Countries

India

Contacts

Public ContactDr Sujay Khandpur

AIIMS NEW DELHI

ankurrathore@aiims.edu9644015606

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026