Functional Test for a Drink Powder: a Randomized, Double-blind, Placebo-controlled Human Consumption Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Skin health (evenness)
研究概览
简要总结
This study is designed to observe human consuming effect of a beauty drink powder and combined use with a cosmetic apparatus. It is a randomized, double-blind, and placebo-control study. The target enrollment of subjects is 160 and 4 arms are included, a placebo control, drink powder alone, cosmetic apparatus alone, and drink powder plus cosmetic apparatus. Effects on skin dullness, skin tone unevenness, skin dryness, skin elasticity, wrinkle and fine line are evaluated. Both objective and subjective methods are used for efficacy evaluation. Data are collected at baseline, week 4, week 8, and week 12 after treatment.
详细描述
In this study, objective parameters are measured by the instruments as following: VisioScan VC20 is used for skin roughness and wrinkle assessment, chromameter CR-400 is used to assess skin color, skin gloss is assessed by Glossymeter, skin hydration is assessed by Corneometer, TEWL is assessed by Vapometer, and skin elasticity is assessed by Cutometer. VISIA-CR and VISIA-7 are used in skin radiation and wrinkle visualization.
Clinical assessment is performed by expert visual grading on
- Skin evenness
- Skin radiance
- Skin elasticity
- Skin smoothness
- Skin firmness
- Skin moisture
- Skin plumpness
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 (Participant, Outcomes Assessor)
盲法说明
In this study, participants and outcomes assessors are masked.
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy male or female
- •Subjects with skin problems such as skin dullness, skin tone unevenness, skin inelasticity, skin dryness, and wrinkle/fine lines.
- •Subjects without any other chronic or on treatment diseases
- •Subjects are voluntary to participate the trial and signed informed consents.
- •Subjects are voluntary to follow all evaluation criteria
排除标准
- •Subjects have a plan to be pregnant, or are in pregnancy or lactation period;
- •Not participated any clinical trial or evaluation within nearly 1 month;
- •Used anti-histamine medication within nearly one week or immunosuppressor within nearly one month
- •Used any anti-inflammation drugs at test site within nearly two months
- •Subjects who have any skin diseases (psoriasis, eczema, skin cancer etc.)
- •Subjects with Type I diabetes
- •Subjects who currently are receiving asthma or other chronic respiratory diseases treatment
- •Subjects who are receiving anti-cancer chemotherapy in nearly 6 months
- •Subjects who have anyother health problem or chronic diseases
- •Subjects who have externally used Vit A, a-hydroxy acid, salicylic acid, hydroquinone within nearly 3 months or prescription medicines, oral contraceptive within nearly 6 months
- •Expert or professional person evaluate have other iatrogenic reason may impact the evaluation results
结局指标
主要结局
Skin health (evenness)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of evenness (using scores from 0-10 to indicate skin evenness from evenness to unevenness) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (elastisity)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of elastisity (using scores from 0-10 to indicate skin elasticity from elastic to nonelastic) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (smoothness)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of smoothness (using scores from 0-10 to indicate skin smoothness from smooth to rough) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (plumpness)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of plumness (using scores from 0-10 to indicate skin plumpness from plump to not plump) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (radiance)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of radiance (using scores from 0-10 to indicate skin radiance from radiance to dulness) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (firmness)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of firmness (using scores from 0-10 to indicate skin firmness from firm to slack) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (moisture)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of moisture (using scores from 0-10 to indicate skin moisture from moist to dry) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
Skin health (overall)
时间窗: baseline, day 28, day 56, and day 84
Change from baseline in investigator facial grading of overall (using scores from 0-10 to indicate overall skin health from good to worse) at days 28, 56, and 84 using Wilcoxon and Mann Whitney two tailed assessment for nonparametric data
次要结局
- Skin Color of L, a, b and ITA value of face determined by chromameter(Baseline, day 28, day 56, and day 84)
- Skin Glossiness of face determined by Glossymeter(Baseline, day 28, day 56, and day 84)
- Skin radiance and lines assessed by facial photo capture using VISIA-CR and VISIA-7(Baseline, day 28, day 56, and day 84)
- Skin hydration of face determined by Corneometer(Baseline, day 28, day 56, and day 84)
- Skin roughness and wrinkle of face determined by VisioScan VC20(Baseline, day 28, day 56, and day 84)
- Skin elasticity of face determined by Cutometer(Baseline, day 28, day 56, and day 84)
- Face TEWL determined by Vapometer(Baseline, day 28, day 56, and day 84)