NL-OMON35782已完成不适用
Consumer exposure to an oxidative hair dye. A [14C]- labelled Toluene-2,5-diamine mass balance study - Consumer exposure to PTD-containing hairdye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Apparently healthy as assessed by the TNO Health and lifestyle questionnaire, limited Physical examination and results of the pre-study laboratory tests
- •2. Age [>= 18 and <= 45] years at Day 01 of the study
- •3. Having given their written informed consent
- •4: Willing to comply with the study procedures
- •5: Hair length of at least 5 cm at inclusion and willing to refrain from hair cutting and hair dye use until day 01 of the study
- •6: Willing to have their coloured hair completely clipped (bald headed!)
- •7: Willing to refrain from blood donation during the whole study
- •8: Willing to use adequate measures to avoid pregnancy during the whole study (females only)
- •9: Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data
- •10: Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
排除标准
- •1. Participation in any clinical trial or medical treatment including administration of a radio labelled test substance up to 1 year before Day 01 of this study
- •2. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •3. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •4. Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine diseases, or dermatological diseases such as having dermatitis or particular skin diseases
- •5. A past history of having had a temporary henna tattoo applied or currently having a temporary henna tattoo
- •6. Prescribed medication (oral contraceptives and paracetamol excluded)
- •7. Bald headed or balding
- •8. Scars, cuts, wounds or dermal abnormalities on the scalp
- •9. Having a known allergy to hair colourants
- •10. Having a positive response to the allergy alert test to the test formulation (higher concentration), conducted 2 days in advance of Day 01 of the study
- •11. Positive pregnancy test (urine) (females)
- •12. Alcohol consumption more than 28 units/week (males) or 21 units /week (females) (1 unit of alcohol equals 10 grams of ethanol)
- •13. Recent blood donation (<1 month prior to the start of the study)
- •14. Not willing to give up blood donation during the study.
- •15. Pregnant or lactating or wishing to become pregnant in the period of the study
- •16. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- •17. Not having a general practitioner
- •18. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
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