EUCTR2006-000292-15-GB进行中（未招募）不适用
A Phase II, Single-Centre, Randomised,Double-Blind, Parallel Group, CPO Solution, Dose Range Finding Study in Subjects with Seborrhoeic Dermatitis of the Scalp
Stiefel Laboratories Maidenhead Ltd.0 个研究点开始时间: 2006年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- •2. Male or female.
- •3. Aged 16 years and above at time of consent.
- •4. Confirmed as having seborrhoeic dermatitis of the scalp, with a traceable area of seborrhoeic dermatitis, as assessed by a consultant dermatologist.
- •5. Willing to wash their hair 3 times a week (every other day) for the duration of the study using the bland shampoo and conditioner provided.
- •6. Overall dandruff severity score of 6 or over at baseline.
- •7. Able to follow the instructions for application of the test product and able to apply the test product directly to the scalp.
- •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. Acute, weeping or infected dermatoses on the scalp, face or ears.
- •2. History of known or suspected intolerance to any of the ingredients of the investigational medicinal product.
- •3. Received any unlicensed drug within 30 days of screening visit or who are scheduled to receive an investigative drug other than the study medication during the period of the study.
- •4. Systemic diseases that, in the opinion of the Investigator, may adversely influence their participation in the trial.
- •5. Female subjects who are pregnant or lactating.
- •6. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered as a medically acceptable form of contraception.
- •7. Considered unable or unlikely to attend the necessary visits.
- •8. Used oral steroids or topical steroids on the scalp within 30 days of screening visit.
- •9. Used any medicinal product (i.e. other than a cosmetic/toiletry anti-dandruff shampoo) for their scalp condition within 30 days of screening visit.
- •10. Known human immunodeficiency virus (HIV) positive status.
- •11. Psoriasis, eczema or any other condition affecting the scalp, face or ears, except for seborrhoeic dermatitis.
- •12. Employees of Chiltern International Limited or Stiefel International R&D, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
研究者
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