NCT05473832已完成不适用
Evaluation of the Anti-aging Efficacy of Four Cosmetic Products
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
- 144
- 试验地点
- 1
- 主要终点
- Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
研究概览
简要总结
The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)
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
- None
入排标准
- 年龄范围
- 40 Years 至 65 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 male
- •From 40 to 65 years of age
- •BMI < 30 kg/m2
- •Healthy skin in the test areas
- •Uniform skin color and no erythema or dark pigmentation in the test area
- •Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
- •Ethnicity: at least one Black, Asian and Hispanic subject per study 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
- •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
- •Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
- •Regular use of tanning beds
- •Any topical medication at the test area within the last 7 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
- •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
结局指标
主要结局
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
时间窗: 8-weeks
次要结局
- Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks(8-weeks)
- Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks(8-weeks)
- Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks(8-weeks)
- Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks(8-weeks)
- Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)(8-weeks)
- Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks(8-weeks)
- Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks(8-weeks)
- Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks(8-weeks)
研究者
研究点 (1)
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