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
干预措施
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
- 1
- 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
研究组 & 干预措施
Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment
Experimental
AmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg
干预措施: AmLactin® Rapid Relief (Other)
Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief
Experimental
AmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg
干预措施: AmLactin® Rapid Relief (Other)
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 Subject Self-Assessment Questionnaire(Baseline, Day 14)
- 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 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 Skin Texture/Roughness (Visual) 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)
研究者
研究点 (1)
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