IVDK Tattoo Study 2.0
Not Applicable
- Conditions
- L23Allergic contact dermatitis
- Registration Number
- DRKS00032904
- Lead Sponsor
- Informationsverbund Dermatologischer Kliniken (IVDK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
non-infectious intolerance reactions to permanent tattoo ink (incl. permanent make-up)
Exclusion Criteria
- refusal or withdrawal of consent to participate in the study
- patients with primary infections or wound healing disorders
- current cytostatic or immunosuppressive therapy
- reactions to temporary tattoos (henna, jagua)
- pregnancy, lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Qualitative determination of: <br>- Pigments<br>- Metals, which may be part of the pigment or present as impurities <br><br>- Patch testing of pigments in order to identify clinically relevant allergens<br><br>- In vitro characterization of T cell-mediated inflammatory reactions to metals and pigments using membrane-bound proteins<br><br>Correlation of the analysis results with<br>- results of patch testing (allergy history using IVDK/Winalldat software)<br>- clinical history data / exposure data recorded with the help of the accompanying information , e.g. histopathological diagnoses <br>- results of laboratory tests of specific T-cells from blood samples (flow cytometry)<br>- with further clinical data (allergy history with the help of IVDK/Winalldat software)<br>- with anamnesis data of the additional questionnaire (extended body art anamnesis)
- Secondary Outcome Measures
Name Time Method (Semi-)Quantitative determination of<br>- pigments<br>- Metals, which may be part of the pigment or present as impurities <br>- binders (e.g. (meth)acrylates), which are present as a component of the color or as an impurity (monomers)<br><br>Correlation of analytical results with <br>- laboratory results<br>- the declaration and chemical analysis of the ingredients in the liquid tattoo inks used (if available) <br><br>Evaluation of inflammation markers and lipid structure of the pigment surrounding tissue<br><br>Identification of individual risk factors by TZR sequencing and HLA genotyping and evaluation of their suitability as differential diagnostic molecular markers.