Effect of a Facial Cream Containing 0.5% Cannabidiol and 0.1% Hemp Oil on Skin Hydration and Characteristics Associated Acne-prone Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Avicanna Inc
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Evaluate the effect on hydration of periodic application of the topical preparation on facial skin
研究概览
简要总结
This research seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD and hemp oil on facial skin as well as the effect on erythema, appearance, instrumentally measured sebum production and quality of life.
详细描述
In this research effort, hypothesis is that application of the topical product improves skin hydration as measured instrumentally by its electric properties as well as other variables associated with skin hydration, sebum production and appearance. Therefore, this research effort seeks to evaluate the short (i.e., after single application) and long-term (i.e., after periodic application) hydrating effect of a topical preparation containing CBD, rosemary extract and hemp oil on facial skin. For this purpose, objective measures aimed at stablishing the change of parameters related to skin water content will be measured. Additionally, other measurements will be obtained to establish the change of different parameters related to the effect on appearance, instrumentally measured sebum production and quality of life. These include: instrumental and subjective measurement of oily skin and standardized photography for assessment of imperfections as well as, a validated assessment of the impact of acne-prone skin on quality of life.
Healthy adults will be invited to participate and the general characteristics of the product will be explained, as well as the amount of time that will be required. The individuals that agree to participate will have to read and sign the informed consent, register contact information, and will be scheduled for visit 0 at the research center within 2 to 7 days. During this period (i.e., washout period), the subject will be told not to use abrasive cleansing products or topical medicines on the facial skin, not to take more than one shower per day, and not to consume caffeine or alcohol 24 hours before attending the research center.
During the washout period the subject will receive a call to confirm compliance with washout requirements as well as visit 0 schedule. If washout conditions are not met, subject will be reminded to comply and visit will be re-scheduled within 2 to 7 days.
In visit 0 at the research center, contact information, demographic variables and standard anthropometric variables will be recorded. Subsequently, the subject will be given detailed information about the research product and protocol, accompanied by an information leaflet with indications regarding the use of the investigational product as well as recommendations on preferred hygiene regimens.
The subject will be able to review the material in a room under controlled ventilation, temperature, humidity and lighting conditions, where he or she will have to stay for a minimum of 30 minutes. After that, in an adjacent room under the same conditions, the basal characteristics of the facial skin will be measured through electrical and photometric variables as well as self-assessment of oily skin, a standardized photograph with visual assessment and self-image questionnaire (i.e., hour 0). The bioengineering measurements will be made on the cheeks (i.e., between the base of the ear lobe and the apex of the chin) and forehead (i.e., exact center of the forehead) and no marking of the measurement area will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin
时间窗: Change from baseline at 2 and 4 weeks
Evaluate the effect on hydration of periodic application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 2 and 4 weeks. Measurement of the water content of the stratum corneum by capacitance.
Evaluate the effect on hydration of a single application of the topical preparation on facial skin
时间窗: Change from baseline at 1 and 3 hours
Evaluate the effect on hydration of a single application of the topical preparation on facial skin, through the direct measurement of its electrical properties as an indicator of water content at 1 and 3 hours. Measurement of the water content of the stratum corneum by capacitance.
次要结局
- Evaluate the short-term change in instrumentally assessed measurement of oily skin(Change from baseline at 1 and 3 hours)
- Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on subjective assessment of oily skin(Change from baseline at 1 and 3 hours)
- Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on the skin appearance(Change from baseline at 2 and 4 weeks)
- Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on quality of life(Change from baseline at 2 and 4 weeks)
- Evaluate the short-term change in instrumentally measured skin biochromophores(Change from baseline at 1 and 3 hours)
- Evaluate the short and long-term tolerance of this topical preparation(0 hours, 1 hour, and 4 weeks)
- Evaluate the short and long-term emollient effect and acceptance of this topical preparation(0 hours, 1 hour, and 4 weeks)
- Evaluate the long-term change in instrumentally assessed measurement of oily skin(Change from baseline at 2 and 4 weeks)
- Evaluate the long-term change in instrumentally measured skin biochromophores(Change from baseline at 2 and 4 weeks)
- Evaluate the long-term effect (i.e., 2 and 4 weeks) of this topical preparation on subjective assessment of oily skin(Change from baseline at 2 and 4 weeks)
- Evaluate the short-term effect (i.e., 1 and 3 hours) of this topical preparation on the skin appearance(Change from baseline at 1 and 3 hours)