A Double-Blind, Placebo Controlled, Half-Head Design, CPO Solution Dose Ranging-Finding Study in Patients with Seborrhoeic Dermatitis of the Scalp - Dose Range-Finding Study

Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel Laboratories International Division)0 个研究点目标入组 60 人开始时间: 2005年4月20日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Provided written Informed Consent
•2. Male or female
•3. Aged 16 years and above
•4. Confirmed as having seborrhoeic dermatitis of the scalp
•5. Willing to have their hair washed only 3 or 4 times weekly for the four week treatment phase of the study, and always at the study site
•6. Overall scaling/flaking meets a minimum visual scaling score of 5, and differing between the bilateral study sites by a score of no more than 1
•7. Willing to have a small section of hair clipped in order to assist in the removal of scales for yeast sampling
•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)
•F.1.3.1 Number of subjects for this age range

•1. Patients with acute, weeping or infected scalp dermatoses
•2. Patients with a history of known or suspected intolerance to any of the ingredients of the investigaional product
•3. Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study
•4. Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial
•5. Female patients who are pregnant or lactating
•6. Patients considered unable or unlikely to attend the necessary follow-up visits
•7. Patients who have used oral steriods, or topical steriods on the scalp, within the previous 4 weeks
•8. Patients who have used any medicinal product (i.e. other than a cosmetic/toiletry anti-dandruff shampoo) for their scalp condition within the previous 4 weeks
•9. Employee of Sequani Clinical of Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.

发起方

Stiefel Laboratories Maidenhead Ltd (commonly known as Stiefel Laboratories International Division)