A Randomized, Double Blind, Controlled Study of Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Skin Moisture
研究概览
简要总结
The goal of this clinical trial is to study the efficacy of collagen supplement on the moisture content and elasticity.
70 participants of 30-50 years old women will be enrolled from two study sites and randomly assigned to use two products (study product plus collagen supplement and placebo product without collagen supplement) for 2 months.
Researchers will compare the two groups to validate the assumption that there is significant improvement on skin anti-aging effect for participants using study product plus collagen supplement.
详细描述
This study is two arms, randomized, double-blind controlled trial. There will be two study sites and 35 eligible participants at each study site will be enrolled with the expectation of having 30 participants completed per study group. Particants will be randomly allocated to use one of the two study products defined in the trial protocol for two months. Up to three study visits will be made by the participant over a 2-month period. All relevant data will be captured and recorded into CTMS (Clinical Trial Management System). The data will be analyzed and reported after the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese females, age between 30-50;
- •Be in general good health;
- •Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
- •Have mild to moderate darker skin tone 3 on Unilever visual scale of 1~9;
- •Have mild pigmentation level 2 on Unilever visual scale of 0~9;
- •Have visual grading score on crow's feet 3 on Unilever visual scale of 0~9;
- •Have visual grading score on peri-oral 3 on Unilever visual scale of 0~9;
- •Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0~9;
- •Tolerate to well-known anti-aging actives;
- •Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study;
- •Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits;
- •Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.).
排除标准
- •Have used any skin lightening /anti-aging benefits products at least one month before this study
- •Subject having done facial injections and/or aesthetic surgery.
- •Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
- •Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
- •Have a history of any type of bagcer, including but not limited to any type of skin bagcer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site.
- •Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study.
- •Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
- •Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation.
- •Have any cuts/abrasions on the test site at baseline.
- •Have had a suspicious skin lesion removed by a dermatologist at any time.
- •The subject is an employee of sponsor or the site conducting the study.
研究组 & 干预措施
Study product plus collagen supplement
5g/bag, containing the following ingredients per 5g serving:
- Collagen tripeptide 1500 mg
- Elastin peptide 150 mg
干预措施: Study product plus collagen supplement (Dietary Supplement)
Study product without collagen supplement
5g/bag, containing the following ingredients per 5g serving:
- Peach juice 8 mg
- Erythritol 10 mg
干预措施: Study product without collagen supplement (Dietary Supplement)
结局指标
主要结局
Skin Moisture
时间窗: baseline day 0, day 60
The changes of skin moisture from baseline to day 60 by Corneometer CM 825
Skin Elasticity
时间窗: baseline day 0, day 60
The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580
次要结局
- Skin Barrier(baseline day 0, day 30, day 60)
- Facial Glow(baseline day 0, day 30, day 60)
- Skin Diagnosis(baseline day 0, day 30, day 60)
- Lines/Wrinkles(baseline day 0, day 30, day 60)