NCT05328388已完成不适用
A 12-week Clinical Study to Evaluate the Efficacy of Oral Lycomato Supplement on Skin Health and Appearance in Healthy Participants.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LycoRed Ltd.
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Expert clinical grading of efficacy attributes
研究概览
简要总结
The study will be performed with oral gels, with up to 55 study subjects who meet the inclusion and non-inclusion criteria required. Study subjects will be instructed to use the products during 12 weeks and they will be assessed and supervised throughout the study by clinic technicians, in order to check for possible adverse events. Efficacy documentation through digital photography, instrumental measurements with the devices Cutometer® MPA 580 and Tewameter®, image acquisition with Visia-CA® as well as self-assessment through questionnaires will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment;
- •50 subjects: 20 Caucasians + 10 Asians + 10 African Americans + 10 Latinos;
- •All Fitzpatrick skin types being II, III and IV for Caucasian/Asian;
- •Subjects to have Glogau skin classification of photoaging, Type 2;
- •Subjects with baseline signs of facial skin aging as conformed by visual expert grading of photographs
排除标准
- •Subjects participating in any other clinical studies;
- •Subjects that underwent beauty injections/ deep pealing/ cosmetic surgery/ tanning- for 3 months before study starts and for all the study duration.
- •Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal impairment, mental illness, drug/alcohol addiction;
- •Unreliable or unlikely to be available for the duration of the study;
- •History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.;
- •Immunocompromised subjects
结局指标
主要结局
Expert clinical grading of efficacy attributes
时间窗: 12 weeks
Visual assessments will be performed by the expert grader using a 10-point ordinal scale on the face.
次要结局
未报告次要终点
研究者
研究点 (2)
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