Bioavailability of tattoo inks by quantifying the marker substances 4-aminobenzoic acid, 2-phenoxyethanol and iodide in blood and urine after tattooing 24 male test persons with black or red color
- Conditions
- bioavailability study
- Registration Number
- DRKS00026022
- Lead Sponsor
- Bundesinstitut für Risikobewertung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
• 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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative determination of the marker substances in blood, urine, tattoo ink & consumables. Blank samples before the tattoo represent subject-related zero controls.
- Secondary Outcome Measures
Name Time Method on-targeted analysis of tattoo inks in blood and urine & use of the data to create a biokinetic modeling of marker substances