In-Use Test With a Cosmetic Product (WO 3308) for Topical Use to Treat Acute or Chronic Pruritus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Cosmetic Features of the Test Product
研究概览
简要总结
The aim of the study is to evaluate the cosmetic features of the product WO 3308 by means of a questionnaire in an interview situation after two weeks of product treatment, giving special consideration to the cosmetic performance, efficacy and skin compatibility and with special focus on the reduction of pruritus. Additionally the tolerance will be evaluated by a dermatologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: ≥ 18 years
- •sex: approx. 25% to 50% male and 50% to 75% female
- •with acute pruritus (lasts less than 6 weeks) or chronic pruritus (lasts longer than 6 weeks): max. 50% with acute pruritus and at least 50% with chronic pruritus
排除标准
- •any deviation from the above-mentioned criteria
- •known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
- •topical medication in the test area within 1 month prior to study start
- •systemic medication with antibiotics within 2 weeks prior to starting of the study
- •change in the medication with anti-inflammatory agents within 2 weeks prior to starting the study
- •systemic medication with immunomodulators (immunsuppressive drugs in the course of a transplantation) and/or chemotherapeutic agents within 4 weeks prior to starting the study
- •neurodermatitis (atopic dermatitis)
- •pregnancy and period of breastfeeding
结局指标
主要结局
Cosmetic Features of the Test Product
时间窗: baseline, two weeks
Change from baseline for the cosmetic features (spreadability, absorbtion, skin feeling after application, fragrance) of the test product by the means of an interview-based questionnaire
Reduction of Pruritus
时间窗: baseline, two weeks
Change from baseline reduction of pruritus at two weeks by the means of an interview-based questionnaire
次要结局
- Tolerance of the Test Product on the skin(baseline, two weeks)