NCT06228833尚未招募不适用
A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines
Yes Skin Medical Group0 个研究点目标入组 50 人开始时间: 2024年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Global aesthetic improvement scale （GAIS） score
研究概览
简要总结
A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet all of the following criteria to be enrolled in the study:
- •Healthy women, skin quality is not limited, aged 25 ~ 65 years old face old ~ moderate aging group;
- •subjects facial skin rough, loose, lack of elasticity;
- •Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;
- •Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;
- •Be able to cooperate well with the tester and maintain the regularity of life during the study;
- •Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);
- •Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;
排除标准
- •Subjects were not included in the study if they met any of the following exclusion criteria:
- •Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);
- •Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
- •Subjects with hypertrophic scar or scar constitution;
- •Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
- •Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
- •Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;
- •Pregnant or lactating women, or recent plans to prepare for pregnancy;
- •Other subjects who are not suitable for participating in this study as assessed by the investigator.
结局指标
主要结局
Global aesthetic improvement scale （GAIS） score
时间窗: at day 90 after procedure
Investigator Satisfaction Assessment Form. Scoring criteria: 3 (very much improved), 2 (marked improvement), 1 (improved), 0 (no change), or -1 (worse).
次要结局
- Global aesthetic improvement scale （GAIS） score(at 30, 60 days after procedure)
- Improvement of skin glossiness(at 30, 60, 90 days after procedure)
- Improvement in dermal thickness/density(at 30, 60, 90 days after procedure)
- Subject satisfaction evaluation(at 30, 60, 90 days after procedure)
- Improvement of transepidermal water loss (TEWL)(at 30, 60, 90 days after procedure)
- Improvement in fine lines score(at 30, 60, 90 days after procedure)
- Improvement in skin elasticity and tightness(at 30, 60, 90 days after procedure)
- Improvement of skin stratum corneum water content(at 30, 60, 90 days after procedure)
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