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
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