Establishment of human in vitro keratinocyte culture models for the study of dermatopharmacological and drug allergy issues
- Conditions
- Drug allergyZ88Personal history of allergy to drugs, medicaments and biological substances
- Registration Number
- DRKS00028025
- Lead Sponsor
- Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
1) Tissue donations from patients: clinically documented association and confirmed diagnosis of drug allergy
2) Tissue donations from control subjects: no drug allergy
3) Donations of skin or hair: healthy skin or hair
4) Circumcidate donors: 0-17 years of age
5) Other tissue donors: 18-90 years of age
6) Written and verbal consent to participate, for minors by both legal guardians
1) Tissue donations from patients: No drug allergy (lack of temporal association and lack of evidence)
2) Tissue donations from control subjects: clinically documented connection and confirmed diagnosis of a drug allergy
3) Donations of skin or hair: pathologically altered skin or hair.
4) Circumcidate donors: >17 years of age
5) Other tissue donors: <18 years of age
6) Lack of capacity to give consent to participate in the study
7) Pregnancy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establishment of human in vitro keratinocyte culture models for the study of dermatopharmacological and drug allergy issues
- Secondary Outcome Measures
Name Time Method 1) Development and characterization of human in vitro keratinocyte culture models 2) Isolation and characterization of drug/metabolite specific lymphocytes from peripheral blood of drug allergic patients 3) Etablierung eines funktionellen In-vitro-Hybridmodells, das eine arzneimittelinduzierte allergische Hautreaktion eines bereits sensibilisierten Patienten nachahmen soll