Establishment of human in vitro keratinocyte culture models for the study of dermatopharmacological and drug allergy issues

Establishment of human in vitro keratinocyte culture models for the study of dermatopharmacological and drug allergy issues - IKem = in vitro keratinocyte culture models

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028025

Enrollment

140

Registered

2022-05-12

Start date

2022-10-10

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Drug allergy Z88

Interventions

Group 1: 1. One-time or repeated skin donation of excess tissue from study-independent tissue removal (e.g. from aesthetic surgery, circumcision). 2. One-time or repeated tissue donation from study-re

hair follicles), blood (40-60ml). 4. Data collection at the beginning of the study participation in data entry form.

Eligibility

Sex/Gender

All

Age

No minimum to 90 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Establishment of human in vitro keratinocyte culture models for the study of dermatopharmacological and drug allergy issues	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactBernhardt Sachs

Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung

bernhardt.sachs@bfarm.de0228/99307-3156

Outcome results

None listed

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