Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 主要终点
- changes in the percentage of area in the red zone of facial skin
研究概览
简要总结
This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •health females aged 35-60;
- •subjects with rough dark, loose fine lines;
- •no history of cosmetic allergies;
- •subjects are willing to use the test serum on split-face for 28 days;
- •subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
- •subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days;
- •written informed consent and portrait right consent were obtained from all participants before study entry.
排除标准
- •anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
- •subjects with known allergies or sensitivities to the ingredients in any of the study products;
- •any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment;
- •unhealed skin lesions;
- •participated in any other clinical trial within one month;
- •received facial skin treatments including but not limited to lasers, chemical peels, and dermal fillers within one month;
- •taken/injected anti-allergy medication in the past one month;
- •participants in other clinical trials at the same time;
- •any subjects that the investigator considers ineligible.
结局指标
主要结局
changes in the percentage of area in the red zone of facial skin
时间窗: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone.
Self-assessment of the facial state questionnaire
时间窗: Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe
次要结局
- changes in transepidermal water loss (TEWL) of facial skin(D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment))
- changes in skin stratum corneum water content(D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment))