NCT04085809已完成不适用
A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and Desquamation of AmLactin® Rapid Relief Treatment in Healthy Female Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change from baseline in D-SQUAME
研究概览
简要总结
The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy female (confirmed by medical history) with Fitzpatrick skin types I-VI
- •dry, rough skin on the anterior shins (defined as Grade 3-4 on the dermatologist evaluation of the skin);
排除标准
- •Had any visible skin disease at the assessment site which, in the opinion of the Investigator, would interfere with the evaluation of the test site
结局指标
主要结局
Change from baseline in D-SQUAME
时间窗: Baseline, Day 2, Day 14
D-SQUAME is a sticky tape that is placed on the skin and the more skin that comes off on the tape, the drier the skin and less moisturization and desquamation.
次要结局
- Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale(Baseline, Day 2, Day 14)
- Change from baseline in overall dry skin scale(Baseline, Day 2, Day 14)
- Change from baseline in Subject Self-Assessment Questionnaire(Baseline, Day 14)
- Change from baseline in Skin Dryness assessed by Dry Skin Scale(Baseline, Day 2, Day 14)
- Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale(Baseline, Day 2, Day 14)
- Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale(Baseline, Day 2, Day 14)
- Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale(Baseline, Day 2, Day 14)
研究者
研究点 (2)
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