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临床试验/EUCTR2007-002478-76-CZ
EUCTR2007-002478-76-CZ进行中(未招募)1 期

Clinical study phase III evaluating the efficacy of Diffusil H Forte spray

ybar a.s.0 个研究点目标入组 110 人开始时间: 2007年5月16日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • a)patients with pediculosis confirmed by a positive dry combing test at Visit 1
  • b)patients able and willing to give written informed consent
  • c)patients able and willing to comply with the requirements of the study
  • d)feasibility of the dry combing test
  • e)age 18- 70 years, male and female
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • a)any scalp condition that makes impossible the feasibility of the dry combing test
  • b)acute conjunctivitis
  • c)clinical signs of eczema exacerbation
  • d)contact eczema in anamnesis
  • e)history of severe allergic or anaphylactic reactions to any ingredients of the tested products
  • f)history of sensitivity to hair shampoo and conditioners
  • g)previous treatment with anti-lice products 2 weeks prior to Visit 1
  • h)concomitant treatment influencing the evaluation of efficacy such as use of trimethoprim or cotrimoxazol within 4 weeks prior to Visit 1
  • i)use of antihistaminics within 3 days prior Visit 1
  • j)participating in another clinical trial within 4 weeks prior to Visit 1
  • k)pregnancy or breast-feeding
  • l)hairdressing such as bleaches, perm or dying

研究者

发起方
ybar a.s.

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