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临床试验/NL-OMON30980
NL-OMON30980已完成不适用

Consumer exposure to oxidative hair dyes. A [14C]-PPD labelled mass balance study. - PPD absorption from hair dye

'Oreal R&D, Worldwide Safety Evaluation0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16

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:Female/Male; Age 18-45 years;
  • 2:Healthy as assessed by health questionnaire, physical examination, clinical chemistry
  • 3:A pregnancy test (dipstick in urine)
  • 4:Having given their written informed consent
  • 5: Willing to have their coloured hair completely clipped (bald headed!)
  • 6:Willing to use adequate measures to avoid pregnancy during the whole study (females only)
  • 7:Willing to refrain from hair cutting (2-3 months) and to let grow their hair to about a 5 cm length on Day01

排除标准

  • 1: 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
  • 2: Positive pregnancy test (urine) (females)
  • 3: Prescribed medication (except oral contraceptives and paracetamol)
  • 4: Having a known allergy to PPD
  • 5: Having a positive response to the retroauricular sensitisation test to PPD, conducted 2 days in advance of Day 01 of the study

研究者

发起方
'Oreal R&D, Worldwide Safety Evaluation

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