bioavailability study
Conditions
Interventions
Group 1: 12 subjects, three marker substances in black ink
Group 2: 12 subjects, three marker substances in red ink
Sponsors
Bundesinstitut für Risikobewertung
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: • Healthy, male test persons, 18 - 45 years of age, who wish to have a tattoo on their own • Weight between 60 and 100 kg • Request a large-area tattoo (approx. 300 cm² for black and 100 cm² for red, each with a deviation of +/- 30%) • At least one tattoo already exists • The subject is able and willing to adhere to the study procedures and instructions
Exclusion criteria
Exclusion criteria: I. Exclusion due to health restrictions: • Any acute or unstable chronic illness that the investigator believes may endanger the subject or impair the conduct of the study: o cardiovascular disease o liver disease o kidney disease o Metabolic diseases (especially thyroid disorders) o Skin disorders in the area of ??the tattoo o tendency to bleed o Suspected active SARS-CoV-2 infection • Serious adverse reaction to previous tattoos (e.g. circulatory collapse, fainting, severe malaise, nausea, headache attacks) • Any kind of illness, especially of the skin, which was triggered or triggered by a previous tattoo: e.g. atopic dermatitis, psoriasis • Diseases of the skin in the area of ??the planned tattoo • Known or suspected allergy / hypersensitivity to a component of the marker substances: potassium iodide or iodine, potassium 4-aminobenzoate, as well as para-substituted aromatic amines (such as benzocaine, procaine, p-hydroxybenzoic acid ester) or 2-phenoxyethanol • Any abnormalities in the parameters of the screening laboratory which, in the opinion of the examiner, could endanger the test subject or impair the conduct of the study, e.g .: o hyperkalemia o renal insufficiency (GFR <45 ml / min) o Increase in liver function values ??(e.g. transaminases) o Hyperthyroidism (low TSH) o Positive HIV, Hepatitis B or C serology II. Exclusion by taking the following drugs or food supplements: • antibiotics • POTABA® antifibrotic • Food supplements containing iodide or (potassium) 4-aminobenzoic acid (PABA) • Anti-thyroid drugs • sulfonamides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative determination of the marker substances in blood, urine, tattoo ink & consumables. Blank samples before the tattoo represent subject-related zero controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-targeted analysis of tattoo inks in blood and urine & use of the data to create a biokinetic modeling of marker substances | — |
Countries
Germany
Contacts
Public ContactInes Schreiver
Bundesinstitut für Risikobewertung
Outcome results
None listed