跳至主要内容
临床试验/EUCTR2004-004830-15-GB
EUCTR2004-004830-15-GB进行中(未招募)1 期

Human Repeat Insult Patch Test with Challenge

Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)0 个研究点目标入组 110 人开始时间: 2005年7月7日最近更新:
适应症

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

  • 1. Male or female
  • 2. Aged 16-65 years
  • 3. Willing and able to provide written informed consent
  • Are the trial subjects under 18? yes
  • 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

  • 1. Females who are pregnant, breast-feeding or of child bearing potential who are not using a medically approved form of contraception
  • 2. Any significant concurrent illness
  • 3. Use of oral or topical steroids
  • 4. Use of any prohibited medications as listed in section 3.6.2
  • 5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients or the patch material (Webril®/Blenderm®)
  • 6. Participation in a repeat insult patch test during the previous 12 weeks
  • 7. Participation in any other research study on the same skin site during the previous 4 weeks
  • 8. Participation in any patch test involving the same skin site in the last 4 to 12 weeks where the skin irritation reactions have not yet completely cleared
  • 9. Concurrent participation in any other research study
  • 10. Presence of irritated skin, tattoos, scars or birthmarks at the test site at screening
  • 11. Employee of Sequani Clinical or Stiefel Laboratories, or an immediate family member (Partner, offspring, parents, siblings or sibling’s offspring) of an employee.

研究者

发起方
Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel International R&D)

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