Consumer exposure to an actual, dark-shaded oxidative hair dye. A [14C]-PPD labelled mass balance study*. - Consumer exposure to PPD

TNO0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1:Female/Male; Age 18-45 years;
•2:Healthy as assessed by health questionnaire, physical examination, clinical chemistry a pregnancy test in urine will be done.
•3:Prescribed medication (oral contraceptives and paracetamol excluded)
•4:Having given their written informed consent
•5:Willing to have their coloured hair completely clipped (bald headed!)
•6:Willing to refrain from blood donation during the whole study
•7:Willing to use adequate measures to avoid pregnancy during the whole study (females only)
•8:Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data
•9: Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
•10: Willing to refrain from hair cutting to let grow their hair to about a 5 cm length on day 01 of the study

•1:Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
•2:Participation in any clinical trial or medical treatment including administration of a radiolabelled test substance up to 1 year before Day 01 of this study
•3: Positive pregnancy test (urine) (females) or lactating
•4: Prescribed medication (except oral contraceptives and paracetamol)
•5: Alcohol consumption more than 28 units/week (males) or 21 units/week (females); 1 unit of alcohol equals 10 grams of ethanol
•6:Having a known allergy to PPD
•7: Having a positive response to the retro-auricular sensitisation test to PPD, conducted 2 days in advance of Day 01 of the study

发起方

TNO