NCT06619457已完成不适用
Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Skin Biological age
研究概览
简要总结
The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 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
- •Female and approximately 10% male (at least 4 male subjects)
- •From 50 to 75 years of age
- •Healthy skin in the test areas
- •Visible wrinkles in the face (grade 3 to 6 according to SGS proderm scale)
- •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
- •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
结局指标
主要结局
Skin Biological age
时间窗: 12-weeks
DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)
Anti-wrinkle efficacy
时间窗: 12 weeks
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. 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)
- Transepidermal Water Loss (TEWL)(12 weeks)
- Mitochondrial morphology in skin(12 weeks)
- Photodocumentation of skin health(12 weeks)
- Subjective questionnaire(12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Anti-ageing Efficacy of a Cosmetic Formulation Containing NMN (2%) Versus PlaceboWrinkleFatiguePuffiness Around the EyesNCT04685096Seneque SA89
已完成
不适用
Evaluation of the Effectiveness of the Anti-aging Effect of a Supplement in Improving Skin ConditionsAging WellNCT05879289Farmoquimica S.A.30
已完成
不适用
Anti-Wrinkle Efficacy Study of an Eye-CreamAgingWrinkleNCT05805735Amazentis SA36
已完成
1 期
Efficacy Determination of Facial Anti-wrinkle Product Aging Solution Anti-wrinkle serumHealthy Thai female subjectsanti-wrinkleTCTR20211208004Aging Solution Co., Ltd.32
已完成
不适用
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of AgingSkin AgingNCT00974480Cosmetique Active International120