DRKS00026022已完成未知
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 - Tat_BioV
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •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
排除标准
- •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
研究者
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