L10.0 L12.0
Conditions
Interventions
Group 1: For the study participants with suspected pemphigus vulgaris (PV) or bullous pemphigoid (BP), the three-dimensional full skin model is used for diagnosis by means of indirect immunofluorescen
Sponsors
Universitätsklinikum der RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All adult male and female patients can participate in this research project, - who are suspected of having a blistering autoimmune skin disease. - understand the nature, significance and scope of the research project - are able to understand and follow the instructions of the study personnel - who have signed an informed consent form
Exclusion criteria
Exclusion criteria: If one of the following criteria applies to the patient, he or she cannot participate in the research project - Minority - Pregnancy and breastfeeding - lack of informed consent - are incapable of giving consent and/or are unable to understand the nature, significance and scope of the research project and to give their consent in writing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this research project is to test a human three-dimensional full-thickness skin model for the diagnosis of the severe blistering autoimmune diseases pemphigus vulgaris (PV) and bullous pemphigoid (BP) using indirect immunofluorescence (IIF). Indirect immunofluorescence (IIF) can be used as a screening test for autoantibodies possibly circulating in the serum in patients with suspected bullous dermatoses. For this diagnostic method, the patient's serum is first incubated on frozen sections of a human three-dimensional full-thickness skin model so that autoantibodies bind to the structural proteins in the test tissue. Fluorescently labelled anti-human IgG sera are then added to bind to the autoantibodies associated with the structural proteins of the tissue. An emerging fluorescence in the microscopic analysis of the tissue sections confirms that autoantibodies against tissue-specific structural proteins are present. The results of this new test system are compared by an experienced dermatohistologist with the results of the established techniques of routine diagnostics of the same patient regarding intensity and localisation of the staining. | — |
Secondary
| Measure | Time frame |
|---|---|
| Another aim of the project is to test a new assay based on vital 3D skin models for targeted therapy planning with biologics in blistering autoimmune dermatoses. 3D skin models can be treated topically or systemically with different substances. Co-incubation of the vital 3D full-thickness skin models with the patient's serum and co-factors that influence disease progression can provide a prediction of a promising form of treatment for the disease. | — |
Countries
Germany
Contacts
Public ContactJens Malte Baron
Klinik für Dermatologie und Allergologie - HautklinikUniklinik RWTH Aachen
Outcome results
None listed