In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Dermatological Tolerance of the Test Product on the Scalp
研究概览
简要总结
The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.
Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.
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
- 是
入选标准
- •age: ≥ 18 years
- •with chronically itchy scalp
- •normal to dry scalp or scalp prone to neurodermatitis
排除标准
- •any deviation from the above-mentioned criteria
- •users of sour hair conditioner
- •subjects who wash their hair more than once a day
- •other dermatological disorders (scars, moles) on the scalp
- •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 anti-inflammatory agents and antibiotics within two weeks prior to starting of the study
- •systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
- •severe internistic disease that leads to pruritus
结局指标
主要结局
Dermatological Tolerance of the Test Product on the Scalp
时间窗: baseline, four weeks
Change from Baseline at four weeks by the means of a dermatological assessment of scalp 1. erythema 2. edema 3. dryness 4. scaliness 5. papules 6. pustules 7. fissures 8. pruritus 9. burning 10. Tension all Parameters (a-j) were assessed by 6-tiered rating scale with 0.5 intervals (0=absent; 0.5=very slight, 1/1.5= slight; 2/2.5=moderate; 3/3.5=severe and 4=extreme)
Subjective Tolerance of the Test Product on the Scalp
时间窗: baseline, four weeks
Change from baseline at four weeks by means of a self-assessment questionnaire (with 13 questions regarding cosmetic features of the product as well as satisfaction with cosmetic performance).
次要结局
- Cosmetic Features of the Test Product(baseline, four weeks)
- Reduction of Pruritus(baseline, four weeks)