NCT05235997Unknown不适用
A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide In Adult Females
Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2022年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change on skin hydration
研究概览
简要总结
The aim of this study is to evaluate the contribution of hydrolized collagen products to elasticity, hydration and roughness of the skin of female volunteers. Safety and tolerability of the product is the other objective of this placebo-controlled, randomized 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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female volunteers aged between 35 and 60 years,
- •Volunteers who have normal physical examination at screening visit,
- •Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
- •Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
- •Volunteers who have understanding of the study and agreement to give a written informed consent.
排除标准
- •Who have atopic constitution or asthma and/or known allergy for biosynthetic collagen products and/or other any of the excipients of the product.
- •Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
- •Who have the use of topical retinoids, anti-wrinkle cosmetic products including retinol and/or AHA, or moisture-rich cosmetic products within the 3 months prior to initiation of the study.
- •Who use skincare therapy using lasers or peeling within the 3 months prior to initiation of the study.
- •Who have current participation in another clinical study, or participation in any type of dermatology study within 3 months.
- •Who have any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
- •Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
- •Who had undergone, or planned to undergo, pregnancy or breastfeeding.
- •Who have current intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
- •Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
- •Who have history of drug abuse.
- •Who have relationship to the investigator.
- •Who are not suitable to any of inclusion criteria.
- •Who have history of difficulty of swallowing.
- •Who are on a special diet due to any reason, or, have gained or lost 5% of baseline weight.
结局指标
主要结局
Change on skin hydration
时间窗: 3 months
Measurement is based on the hydration of the stratum corneum through the capacitive method by using an instrument specifically developed for assign skin health.
Change on skin elasticity
时间窗: 3 months
Measurement of elasticity based on the stress/deformation method through skin suction by using an instrument specifically developed for assign skin health.
次要结局
- Change on skin roughness(3 monhs)
研究者
研究点 (2)
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