Klinische Untersuchung Zur Pflege Trockener Haut Mit Physiogel AI Lotion Und Physiogel Lotion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life
研究概览
简要总结
Dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of tension, burning and itching can occur. Dry skin needs special care due to its structural and functional characteristics.We monitor an application test the Dermatocosmetics Oilatum Physiogel AI Lotion and Physiogel Lotion. This is to be accomplished with patients having dry skin. The influence on the roughness of skin, desquamation, feeling of tingle, burning and itching should be documented. If sleep quality is disturbed by tingle or itch, this will be monitored, too.
详细描述
The included patients use the lotion twice daily for a two-week period. If not sufficient it can be continued up to a four-weeks period. Additionally, the patient receives a documentation sheets to note several parameters. In a sensory assessment, product specific parameter such as spreadability, permeability, lubricating, smell of lotion and cosmetic acceptance during the treatment will be assessed (at the beginning, after 2 weeks, after 4 weeks, 2 weeks after stopping treatment). After four weeks the skin care measurement will be terminated and the patient can continue with a treatment of his choice. A monitoring of at least 50 patients per preparation is intended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age: over 18 years
- •Willing to apply skin care for 2 to 4 weeks, twice daily
- •Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching
排除标准
- •Participation in any other research study during the previous 4 weeks.
- •Previous participation in this study.
- •Concurrent participation in any other research study involving an investigational product.
- •Current need for the use of topical steroids.
- •History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
- •Subjects considered unable or unlikely to fulfill diaries.
- •Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
- •History of cancer.
- •Recent immunization (less than 10 days prior to the use of the test product).
研究组 & 干预措施
I
Physiogel AI Lotion
干预措施: Physiogel AI Lotion, Physiogel Lotion (Drug)
II
Physiogel Lotion twice daily
干预措施: Physiogel AI Lotion, Physiogel Lotion (Drug)
结局指标
主要结局
Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life
时间窗: two weeks
Improvement of burning, stinging and pruritus (if present)
时间窗: two weeks
Improvement of quality of life
时间窗: two weeks
次要结局
未报告次要终点