NCT05300984已完成不适用
Evaluation of the Anti-aging Efficacy of a Novel 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
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
研究概览
简要总结
The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.
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
- 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 50 to 75 years of age
- •Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
- •Healthy skin in the test areas
- •Vaccination of tetanus within the last 10 years (for biopsy sub group)
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
- •Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- •Diabetes mellitus (type 1 and 2)
- •One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
- •Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
- •Intolerability against adhesive dressing (e.g. acrylate)
- •Active skin disease at the test area
- •Regular use of tanning beds
- •Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
- •Any topical medication at the test area within the last 3 days prior to the start 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
- •Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
- •Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
- •Therapy with antibiotics within the last 2 weeks prior to the start of the study
- •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
- •Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
- •History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
结局指标
主要结局
Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
时间窗: 8 weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks
时间窗: 8 weeks
次要结局
- Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks(8 weeks)
- Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks(8 weeks)
- Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks(2-weeks)
- Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks(2 and 8 weeks)
- Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks(8 weeks)
- Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks(8 weeks)
- Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks(8 weeks)
- Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks(8 weeks)
研究者
研究点 (1)
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