NCT05803083已完成不适用
The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-
Bloomage Biotechnology Corp., Ltd.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline skin viscoelasticity
研究概览
简要总结
This clinical trial aims to clarify the effect of hyaluronic acid on skin conditions.
详细描述
In this study, investigators will evaluate the skin condition before and after the intervention. The groups to be compared are two different doses of hyaluronic and a placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Japanese women between 30 and 60 years of age at the time of obtaining consent to participate in the study.
- •Healthy individuals with no chronic physical diseases, including skin diseases.
- •Person with sagging, dry, or flaky skin.
- •Person who have been fully informed of the purpose and content of the study, have the capacity to consent, understand it well, and voluntarily volunteer to participate in the study, and are able to consent to participation in the study in writing.
- •Person who be able to come to the study site on the designated examination date and undergo the examination.
- •Person who are deemed suitable by the investigator to participate in the study.
排除标准
- •Those who currently suffer from some disease and are receiving drug treatment.
- •Patients with skin disease symptoms such as atopic dermatitis.
- •Patients who have scars or inflammation on the evaluation site.
- •Patients who have taken or applied drugs in the past month for the purpose of treatment of the disease (excluding those who have taken drugs for headache, menstrual cramps, common cold, etc.).
- •Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
- •Patients with comorbidities and serious history of gastrointestinal disorders.
- •Patients with severe anemia.
- •BMI of 30.0 kg/m2 or more.
- •Person who are allergic to any ingredient in the test food or who are at risk of developing serious allergic reactions to any other food or drug.
- •person is currently, or within the past 3 months has been, or will be during the study period, a habitual consumer of functional foods, health foods, or supplements containing active ingredients similar to those in the test food.
- •Currently, and within the past 3 months, those who have or will take functional foods, health foods, or supplements that claim to improve skin on a regular basis during the study period (consumption for the purpose of maintaining good health is acceptable).
- •Currently, or within the past 3 months, those who have a habit of continuously taking or applying drugs that are claimed to improve the skin.
- •Pregnant, lactating, or of child-bearing potential.
- •Patients whose daily alcohol consumption exceeds an average of 60g/day of pure alcohol equivalent.
- •Patient with mental disorders.
- •Persons with a smoking habit.
- •Those who may change their lifestyle during the examination period (e.g., work at night, travel for long periods of time, etc.).
- •Patient who may develop seasonal allergic symptoms such as hay fever and may use medicines during the study period.
- •Persons who will be extremely neglectful of their skin care.
- •Those who intentionally cannot refrain from being exposed to direct sunlight, such as sunburn, during the examination period.
- •Person with a history of cosmetic procedures or treatments on the evaluation site within the past 6 months.
- •Person with currently participating in another human clinical trial, or who have not yet completed 3 months of participation in another human clinical trial.
- •Person who are judged by the investigator to be inappropriate for this study.
结局指标
主要结局
Change from baseline skin viscoelasticity
时间窗: Week0, 2, 4, 8 and week 4 after the end of intake
In skin viscoelasticity measurement using Cutometer MPA580®, skin displacement is measured by applying negative pressure to the skin through the opening of the probe and releasing the negative pressure. The higher the value, the greater the viscoelasticity. Measurement part：Measure the center of the left face, connecting the bottom of the earlobe and the edge of the lip. Accepted value：Measure the same place 5 times, and use the average of 3 measurements with the highest and lowest value data removed based on the R2 value. Analysis target value：R0, R2, R5, R7
次要结局
- Change from baseline face visual evaluation(Week0, 2, 4, 8 and week 4 after the end of intake)
- Change from baseline skin moisture content(Week0, 2, 4, 8 and week 4 after the end of intake)
- Change from baseline trans-epidermal water transpiration(Week0, 2, 4, 8 and week 4 after the end of intake)
- Change from baseline VISIA image(week 0, 2, 4, 8 and week 4 after the end of intake)
研究者
研究点 (2)
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