Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Skin pH
研究概览
简要总结
The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent to participate in the study
- •Willingness to actively participate in the study and to come to the scheduled visits
- •Female and male (at least 30% male subjects)
- •From 50 to 75 years of age, equally distributed
排除标准
- •Female subjects: Pregnancy or lactation
- •Drug addicts, alcoholics
- •AIDS or infectious hepatitis if known to the subjects
- •Conditions which exclude a participation or might influence the test reaction/ evaluation
- •Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
- •Active skin disease at the test area
- •One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes
- •Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation
研究组 & 干预措施
A - Negative control (untreated) for product C
On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C
B - Negative control (untreated) for product D
On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D
C - Cosmetic Product WO 3741 with pH 4
On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D.
干预措施: C - pH 4 Cosmetic Product WO 3741 (Other)
D - Cosmetic Product WO 4081-1 with pH 5.8
On the forearms four test areas were located, which were labeled from A-D.
干预措施: D - pH 5.8 Cosmetic Product WO 4081-1 (Other)
结局指标
主要结局
Skin pH
时间窗: baseline, Day 29, Day 30
Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter
次要结局
- Transepidermal Water Loss(baseline, Day 29, Day 30)
- Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))(baseline, Day 29, Day 30)
- Skin Hydration(baseline, Day 29, Day 30)
- Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)(baseline, Day 29, Day 30)