NCT07517887已完成不适用
Anti-aging Efficacy Study on One Cosmetic Product vs Untreated
适应症
干预措施
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
- 1
- 主要终点
- Skin hydration
研究概览
简要总结
The aim of this study is to investigate the impact of a topical product on skin health and 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
- Single (Outcomes Assessor)
盲法说明
Double (Outcomes Assessor)
入排标准
- 年龄范围
- 45 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
- •Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.
- •Willingness to actively participate in the study and to come to the scheduled visits
- •Male, approximately 10 to 15% with little facial hair
- •From 45 to 65 years of age
- •Healthy skin in the test areas
- •Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)
排除标准
- •Female participants: 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 or their ingredients
- •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 within the last 6 weeks prior to the start of the study
- •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) within the last 7 days prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
- •Therapy with antibiotics within the last 2 weeks prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study
- •Cosmetic surgery procedure in the test area (e.g. laser, facelift) within the last 2 years and throughout the entire course of the study
- •Cosmetic surgery treatments 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 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 and throughout the entire course of the study
研究组 & 干预措施
Cosmetic routine
Experimental
The "cosmetic routine" arm will apply the skin care product
干预措施: Skin care product (Other)
Untreated control
No Intervention
The "Untreated control" arm will not apply the skin care product
结局指标
主要结局
Skin hydration
时间窗: 8 weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 2 and 8 weeks
次要结局
- Anti-wrinkle efficacy(8 weeks)
- Skin barrier function(8 weeks)
- Skin firmness(8 weeks)
- Skin elasticity(8 weeks)
- Clinical skin appearance(8 weeks)
- Skin aging hallmarks(8 weeks)
- Product traits(8 weeks)
- Clinical Before-After Photography(8 weeks)
研究者
研究点 (1)
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