A Randomized Double-blind Controlled Study of Collagen Efficacy on Skin Anti-aging in 30 to 50-Year-Old Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Skin Elasticity
研究概览
简要总结
This goal of this clinical trial is to study the efficacy of collagen supplement on skin moisture and elasticity in middle-aged women of 30-50 years old.
Participants will be assigned two products with and without collagen supplement and use for 2 months, twice a day.
Researchers will compare the two groups whether there are siginificant improvement of skin moisture and elasticity for participants via skin measurement and anaysis system.
详细描述
This is a two arms, randomized, double-blind controlled trial. Study product plus collagen supplement and placebo product but without collagen will be randomly assigned to 70 eligible participants who will be enrolled at two study sites in Shanghai. Participants need to use the assigned product one bottle (25ml) each time, twice a day and visit the study site for three times (baseline day, day 30 and day 60) during the 2-month study. For each visit, the primary outcomes (skin hydration and skin elasticity) and secondary outcomes (skin barrier, lines/wrinkles, and facial glow,etc.) will be measured with professional equiment and imaging system and recorded to data management system. At the end of the study, the study data will exported and analyzed to validate the assumption that the collagen could improve skin moisture content and elasticity in middle-aged women of 30-50 years old.
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 bottlecer, including but not limited to any type of skin bottlecer (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.
结局指标
主要结局
Skin Elasticity
时间窗: baseline day 0, day 30, day 60
The changes of skin elasticity by CK Cutometer MPA580
Skin Moisture
时间窗: baseline day 0, day 30, day 60
The changes of skin moisture by Corneometer CM 825
次要结局
- Skin Barrier(baseline day 0, day 30, day 60)
- Lines/Wrinkles(baseline day 0, day 30, day 60)
- Skin Diagnosis(baseline day 0, day 30, day 60)