NCT07393191已完成不适用
Clinical Instrumental Evaluation of the Efficacy of a Cosmetic Product in Improving Skin Moisturization and Skin Barrier
Lacer S.A.1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年12月17日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in skin moisturization from baseline to 28 days
研究概览
简要总结
The goal of this clinical trial is to learn if a cosmetic product works to improve skin condition in adults with dry, very dry, sensitive and cracked skin showing discomfort. The main questions it aims to answer are:
- Does the cosmetic increase skin hydration and skin barrier function?
- Does the cosmetic improve skin discomfort signs? Researchers will compare the skin condition with and without product use to see if it works to improve dry, sensitive and cracked skin.
Participants will:
- Use cosmetic twice a day for 1 month
- Visit the research center on day 1, 2, 7 and 28 of product use for evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects (without specific repartition)
- •Caucasian ethnicity
- •Aged between 18 and 65 years old
- •Subjects with dry (<30 c.u.), very dry (<25 c.u.), sensitive and cracked skin
- •Subjects must show all the listed skin discomforts (skin dryness, desquamation, skin tightness, and itching
- •Subjects aware of the study procedures and having signed an informed consent form
- •Subjects registered with National Health Service (NHS)
- •Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •Subjects able to understand the language used in the investigation and to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- •Commitment not to change the daily routine or the lifestyle
- •Subject informed about the study procedures and having signed the privacy policy
排除标准
- •Subjects who do not fit the inclusion criteria.
- •Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- •Subjects participating or planning to participate in other clinical trials
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects not able to be contacted in case of emergency
- •Subjects admitted to a health or social facility
- •Subjects planning a hospitalization during the study
- •Subjects who participated in a similar study without respecting an adequate washout period (14 days)
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
- •Cosmetic treatment known to interfere with the tested product (e.g.: laser, peeling)
- •Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Subjects intolerant or allergic to one or more ingredients of the cosmetic product
- •Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
- •Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
研究组 & 干预措施
subjects applied tested product on one leg and the other leg was left untreated (control)
Experimental
Subjects applied tested product on right or left leg (as per randomization) and the other leg was left untreated and acted as control area. The product was applied twice a day during 1 month.
干预措施: Repairing cream (Other)
Untreated
No Intervention
No product application
结局指标
主要结局
Change in skin moisturization from baseline to 28 days
时间窗: Change from baseline in skin hydration at 30min, 24 hours, 48 hours, 7 days and 28 days.
Skin hydration defined as skin capacitance value measured by Corneometer. Higher value means more hydrated skin.
Change in skin barrier function from baseline to 28 days
时间窗: Change from baseline in skin barrier function at 30min, 24 hours, 48 hours, 7 days and 28 days.
Skin barrier function defined as transepidermal water loss value measured by Tewameter. Lower value means improved skin barrier function.
次要结局
- Assessment of product acceptability(Subjects responded to questionnaires at 30min, 24 hours, 48 hours, 7 days and 28 days of product use.)
研究者
研究点 (1)
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