NCT05048121已完成不适用
Multicentric, Randomized, Placebo Controlled, Intra-subject, Double Blind Study to Evaluate the Moisturizing Efficacy of a Dermo-cosmetic Product (CLS02021) Versus a Standard Moisturizer During a 4-week Application Period in Healthy Subjects
Anbiome Labs LLC4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Moisturizing efficacy
研究概览
简要总结
This study will explore the potential of probiotic based, novel cosmetic active ingredient to rebuild the collagen based skin barrier with the overall aim to rejuvenate ageing or damaged skin, improve skin integrity, appearance, beauty, and support personal well-being and vitality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized, double blind, placebo controlled. All products will be packed in the identical packaging and will be labeled in accordance to randomization technique.
Label will contain: 4 digit, randomization code of the sample and visible sign "LEFT" or "RIGHT".
Visible sign ''Left'' or ''Right'' will indicate the side of the face the product will be applied.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female subjects aged 18 to 69 years
- •Subjects who have given and signed written informed consent
- •Subjects who are willing to comply with the study requirements
排除标准
- •Subjects with any systemic disorder or face dermatoses including acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
- •Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
- •Subjects with a history of skin cancer
- •Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid ...) in the 3 months prior the study inclusion
- •Subjects who are sensitive to any compound in the base cream
- •Subjects who are sensitive to any active cosmetic compound including Sphingomielinaze, Hylauronic Acid, Lactic Acid or Lipothecoic acid
- •Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
- •Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
- •Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
- •Subjects having applied any topical products on face (including make- up) the day of the study inclusion
- •Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
- •Subjects belonging to the staff of the study center
- •Subjects in an exclusion period or participating in another biomedical research study
结局指标
主要结局
Moisturizing efficacy
时间窗: 4 weeks
Change in Instrument measured hydration and elasticity using corneometry (Bioelectrical Impedance Analysis) on the face from baseline to Week 4 (performed by dermatological examiner-blinded)
次要结局
- Wrinkle depth / Skin quality effect(4 weeks)
- Sensitivity / Skin quality effect(4 weeks)
- Sebum production / Skin quality effect(4 weeks)
- Pore size / Skin quality effect(4 weeks)
- Melanin production / Skin quality effect(4 weeks)
- Pore cleanliness / Skin quality effect(4 weeks)
- Local Tolerance and Safety(4 weeks)
- Self-perceived efficacy(4 weeks)
- Sensory evaluation(4 weeks)
研究者
研究点 (4)
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