Oral Supplementation With Low Molecular Weight Collagen Peptides Improves Facial Wrinkles and Skin Hydration: Results From a Six-Week Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- R0= Skin firmness (mm)
研究概览
简要总结
The present study aims to investigate the efficacy of daily supplementation with COLLinstant® LMW over a 6-week period in improving visible signs of aging. This in-cludes assessing its impact on skin wrinkle reduction, as well as its potential to en-hance skin elasticity and moisturization. COLLinstant® LMW was administered orally in a single-center, randomized, double-blind, placebo-controlled clinical trial. A sec-ondary objective involves comparing skin improvement, product satisfaction, and monitoring adverse events among middle-aged female volunteers.
详细描述
Study design and ethical aspects This was a 6-week, prospective, randomized, placebo-controlled, double-blind, monocentric study performed at GALA Laboratories in Don Benito-Villanueva (Badajoz, Spain).
Participants were individually randomized (1:1 ratio) to a strategy of receiving either COLLinstant® LMW (collagen group) or a placebo regimen and followed up for 6 weeks. Subjects were instructed to dose both product regimens as per the manufacturer's package instructions or, when appropriate, investigator guidance.
The investigation was performed according to the ethical guidelines detailed in the Declaration of Helsinki (amendment of the 64th General Assembly, Fortaleza, Brazil, October 2013) and with national regulations of Spain, and in full compliance with the applicable principles of good clinical practice (GCP) and International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. The trial protocol was approved (code 075-2022) by the Clinical Research Ethics Committee at the University Hospital of Cáceres (Caceres, Spain) and written informed consent was obtained from all subjects prior to any study procedures being ini-tiated.
Intervention/study products The test product is classified as a food supplement. The preparation under study was COLLinstant® LMW (Viscofan DE GmbH, Weinheim, Germany), an oral food supplement based on bovine bioactive hydrolyzed type I and III-collagen peptides.
Following ICH-GCP requirements and applicable local regulations, the inves-tigational product and placebo were presented as a powder for oral suspension and sealed in sachets that were identical in appearance and odor.
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, Investigator)
盲法说明
Randomized, Double-Blind, Placebo-Controlled Study
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women (aged 30-65 years) with phototypes I-IV, who were mentally and physically healthy, had a BMI 20.0-29.9 kg/m2 and displayed visible signs of natural and photoaging on their face (crow´s feet) rated from moderate to severe
排除标准
- •Pregnancy, lactation, acute or chronic skin disease or dermatological disorder; use of natural health supplements for improving the skin within 1 month before the start of the study; low protein diet; planned or unavoidable exposure to UV radiation; tattoos on or near the test area; use of systemic corticosteroids or applied topical alpha hydroxyl acids near the test site within 4 weeks of enrolment; use of topical medications near the test area within 6 weeks of enrolment; Botulinum toxin A (Botox) treatment or filler injection (collagen, hyaluronic acid, etc) near the test sites within 2 years of enrolment; subjects cognitively impaired and/or unable to give informed consent; or had any other condition which in the medical investigator's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual.
结局指标
主要结局
R0= Skin firmness (mm)
时间窗: 6 weeks
R0 was used as a measure of skin firmness (mm), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties
R9= Skin fatigue (mm)
时间窗: 6 weeks
R9 was used as a measure of skin fatigue (mm), assessed at the crow's feet region, so a Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties
Skin wrinkling area (px^2)
时间窗: 6 weeks
Measurement of skin wrinkling area (px\^2) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)
R7= Skin elastic recovery (%)
时间窗: 6 weeks
R7 was used as a measure of skin elastic recovery (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties
R2= gross elasticity (%) of the skin
时间窗: 6 weeks
R2 was used as measure of skin gross elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties
R5= Skin net elasticity (%)
时间窗: 6 weeks
R5 was used as measure of skin net elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties
Skin wrinkling volume (px^3)
时间窗: 6 weeks
Measurement of skin wrinkling volume (px\^3) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)
Skin hydration (AU)
时间窗: 6 weeks
Measurement of skin hydration (AU) of the stratum corneum was performed at each study visit by the electrical capacitance method using a Corneometer® CM 825 (Courage \& Khazaka, Cologne, Germany).
Skin wrinkling depth (px)
时间窗: 6 weeks
Measurement of skin wrinkling depth (px) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)
次要结局
- Opinion on the degree of satisfaction with the product(At (T6), six weeks after the trial began)
- Subjective perception of product efficacy(At (T6), six weeks after the trial began)
- Subjective perception of the organoleptic characteristics of the product(At (T6), six weeks after the trial began)