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Clinical Study on Precise Diagnosis of Bullous Skin Disease Based on Nanofluorescence Probes

Clinical Study on Precise Diagnosis of Bullous Skin Disease Based on Nanofluorescence Probes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300079051
Enrollment
Unknown
Registered
2023-12-25
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Bullous skin disease

Interventions

Gold Standard:ELISA results for BP180, BP230, Dsg1, and Dsg3
Index test:Nanofluorescence immunochromatography

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 99 Years

Inclusion criteria

Inclusion criteria: Selection criteria for positive samples of bullous pemphigoid: ? The main manifestation is tension blisters on the basis of erythema on the skin, and Nielsen's sign is negative; ? The histopathology is a subepidermal blister with infiltration of inflammatory cells mainly composed of eosinophils in the dermis; ? Deposition of IgG and/or C3 in the patient's skin DIF basement membrane zone; ? Salt splitting indirect immunofluorescence examination showed linear deposition of immune complexes (IgG and/or C3) on the epidermal side; ? BP180 antibody test positive (ELISA value>9U/ml); Which conforms to ? and ?; Or if it meets ?, ?, ?+[? or ?], it can be selected Selection criteria for positive samples of pemphigus: ? Loose blisters appear on the skin and/or mucous membranes, with positive Nissl's sign; ? Histopathological examination revealed lysis cells in the spinous layer; ? Direct immunofluorescence showed deposition of IgG and/or C3 between keratinocytes; ? Dsg1 and/or Dsg3 ELISA values>20 U/ml. Conforming to ?+?+? or ?; ?+? Or ? or ? can be selected. Negative sample selection criteria: serum samples from other skin disease patients or healthy individuals without symptoms of bullous skin disease. All selected patients and healthy volunteers are required to sign an informed consent form.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Sensitivity;specificity;accuracy;

Secondary

MeasureTime frame
ROC curve;

Countries

China

Contacts

Public ContactPengfei Zhang

Shanghai Skin Disease Hospital

pfzhang2014@163.com+86 131 6213 9235

Outcome results

None listed

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