Anti-aging Efficacy Study With Food Supplement and Cosmetic Routine vs Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Anti-wrinkle efficacy
研究概览
简要总结
The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent to participate in the study
- •Willingness to actively participate in the study and to come to the scheduled visits
- •From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
- •Healthy skin in the test areas
- •Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)
- •For biopsy subpanel:
- •Vaccination of tetanus within the last 10 years
排除标准
- •Female subjects: Pregnancy or lactation
- •Drug addicts, alcoholics
- •AIDS, HIV-positive or infectious hepatitis
- •Conditions which exclude a participation or might influence the test reaction/evaluation
- •Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- •Active skin disease at the test area
- •Documented allergies to face/eye care products and food supplements or their ingredients
- •Intake of dietary supplements within the last 3 months before the start of the study
- •Diabetes mellitus
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- •One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
- •Regular use of tanning beds
- •Any topical medication at the test area within the last 3 days prior to the start of the study
- •Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
- •Therapy with antibiotics within the last 2 weeks prior to the start of the study
- •Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
- •Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study
- •Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study
- •For biopsy subpanel:
- •Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
- •History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
- •Known intolerance to local anaesthetics
- •Known Sensitivity to any dressing systems
研究组 & 干预措施
Food supplement and cosmetic routine
The "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active.
干预措施: Food Supplement active (Dietary Supplement)
Food supplement and cosmetic routine
The "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active.
干预措施: Skin care product active (Other)
Food supplement
The "food supplement" arm will consume the food supplement active and apply the skin care product placebo.
干预措施: Food Supplement active (Dietary Supplement)
Food supplement
The "food supplement" arm will consume the food supplement active and apply the skin care product placebo.
干预措施: Skin care product placebo (Other)
Cosmetic routine
The "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active.
干预措施: Food supplement placebo (Dietary Supplement)
Cosmetic routine
The "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active.
干预措施: Skin care product active (Other)
Placebo
The "placebo" arm will consume the food supplement placebo and apply the skin care product placebo.
干预措施: Food supplement placebo (Dietary Supplement)
Placebo
The "placebo" arm will consume the food supplement placebo and apply the skin care product placebo.
干预措施: Skin care product placebo (Other)
结局指标
主要结局
Anti-wrinkle efficacy
时间窗: 12 weeks
Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
次要结局
- Skin hydration(12 weeks)
- Skin barrier function(12 weeks)
- Skin firmness(12 weeks)
- Skin elasticity(12 weeks)
- Wrinkles and fine lines(12 weeks)
- Skin aging hallmarks(12 weeks)
- Product traits(12 weeks)