NCT05748470招募中不适用
A Prospective, Single-center, Single-blind, Randomized Split-face Controlled Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging in Real World Clinical Practice
Yes Skin Medical Group1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 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 satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy combined with SkinCeuticals A.G.E. Participants will be treated with ultrasound combined with SkinCeuticals A.G.E on one randomized side face and ultrasound combined with standard cream on the other side.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese subjects aged 18-65 years inclusive;
- •The subject 's facial skin is rough, flaccid, and lack of elasticity;
- •Subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening;
- •Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
- •Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
- •Subjects understand the nature of the study and sign the informed consent form (ICF).
排除标准
- •Subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to A.G.E use (or allergic to other skin care components);
- •Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
- •Subjects with hypertrophic scar or scar constitution;
- •Receiving treatment of tightening medical treatment program (Thermage/Fotona 4D/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months;
- •Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
- •Subjects who have participated in drug clinical trials or other trials within the past 30 days (or are participating in), or have used drugs affecting the test results within 1 week;
- •Female subjects who are pregnant, lactating or plan to become pregnant;
- •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: 5 (very much improved), 4 (marked improvement), 3 (improved), 2 (no change), or 1 (worse).
次要结局
- Relative change in transepidermal water loss(TEWL) from baseline(at 30, 60, 90, 180 days after procedure)
- Relative change from baseline in dermal thickness(at 30, 60, 90, 180 days after procedure)
- Relative change from baseline in skin elasticity(at 30, 60, 90, 180 days after procedure)
- Investigator satisfaction assessment(at 30, 60, 90, 180 days after surgery)
- Global aesthetic improvement scale （GAIS） score(at day 30,60,180 after procedure)
- Subject satisfaction evaluation(at 30, 60, 90, 180 days after procedure)
- Change from baseline in fine lines score(at 30, 60, 90, 180 days after procedure)
研究者
研究点 (1)
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