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IVDK Tattoo Study 2.0

IVDK Tattoo Study 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032904
Enrollment
50
Registered
2023-10-19
Start date
2023-11-01
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

L23

Interventions

Group 1: Patients with non-infectious skin reactions to permanent tattoo ink will be recruited in the dermatological centers of the Information Network of Departments of Dermatology (IVDK) from Novemb

Sponsors

Informationsverbund Dermatologischer Kliniken (IVDK)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: non-infectious intolerance reactions to permanent tattoo ink (incl. permanent make-up)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Qualitative determination of: - Pigments - Metals, which may be part of the pigment or present as impurities - Patch testing of pigments in order to identify clinically relevant allergens - In vitro characterization of T cell-mediated inflammatory reactions to metals and pigments using membrane-bound proteins Correlation of the analysis results with - results of patch testing (allergy history using IVDK/Winalldat software) - clinical history data / exposure data recorded with the help of the accompanying information , e.g. histopathological diagnoses - results of laboratory tests of specific T-cells from blood samples (flow cytometry) - with further clinical data (allergy history with the help of IVDK/Winalldat software) - with anamnesis data of the additional questionnaire ("extended body art anamnesis")

Secondary

MeasureTime frame
(Semi-)Quantitative determination of - pigments - Metals, which may be part of the pigment or present as impurities - binders (e.g. (meth)acrylates), which are present as a component of the color or as an impurity (monomers) Correlation of analytical results with - laboratory results - the declaration and chemical analysis of the ingredients in the liquid tattoo inks used (if available) Evaluation of inflammation markers and lipid structure of the pigment surrounding tissue Identification of individual risk factors by TZR sequencing and HLA genotyping and evaluation of their suitability as differential diagnostic molecular markers.

Countries

Austria, Germany, Switzerland

Contacts

Public ContactSteffen Schubert

Informationsverbund Dermatologischer Kliniken (IVDK)

sschube4@gwdg.de+49 551 505 39 622

Outcome results

None listed

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