A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging
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
- 2
- 主要终点
- Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
研究概览
简要总结
This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use both the test product and the positive control product (0.1% Retinol Clinical Trial Lotion). Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60. Photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18-
- •Have one or more of the following: visible fine lines and wrinkles, dry skin, reduced skin elasticity, or generally unhealthy skin.
- •Must be willing to use two different skincare products, one on each side of their face for the duration of the trial.
- •Have a smartphone or camera to take before-and-after selfies.
排除标准
- •Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
- •Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
- •Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
- •Anyone who cannot/ will not commit to the study protocol. Anyone with a history of substance abuse.
研究组 & 干预措施
Test Arm
All participants will use both the test product and the active control. Participants will use the creams in the evening, applying the TBT Cream to the right side of the face, and the positive control on the left side of the face.
干预措施: Dime Beauty TBT Cream (Other)
Test Arm
All participants will use both the test product and the active control. Participants will use the creams in the evening, applying the TBT Cream to the right side of the face, and the positive control on the left side of the face.
干预措施: Positive Control (Other)
结局指标
主要结局
Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
时间窗: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Change in skin elasticity. [Baseline to Day 60]
时间窗: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in participants' perception of signs of skin aging. [Baseline to Day 60]
时间窗: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Change in participants' perception of the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
时间窗: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in signs of skin aging. [Baseline to Day 60]
时间窗: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Changes in participants' perception of facial skin hydration. [Baseline to Day 60]
时间窗: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in facial skin hydration. [Baseline to Day 60]
时间窗: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
次要结局
- Comparison of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60](60 days)
- Comparison of participants perception of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60](60 days)