A Clinical Evaluation of the Efficacy of the Density Device for Non-Invasive Body Contouring over a 3-Month Period
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in body contour of the treatment site in comparison to baseline based on dermatological and instrumental evaluations
研究概览
简要总结
This clinical study aims to assess the performance of the Jeisys Density device for body contouring in female participants aged 25 to 60 years. A total of four visits will be scheduled: Visit 1 for screening, Visit 2 for baseline, procedure, and immediate post-procedure assessment, Visit 3 on Day 30, and Visit 4 on Day 90 for follow-up evaluations. Changes in body measurements and contour at the treatment site will be assessed using dermatological, instrumental, and patient-reported evaluations. Safety will be monitored throughout the study to identify any adverse effects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Trial participants aged between 25-60 years.
- •Skin Laxity: Visible mild to moderate skin laxity or sagging.
- •Participants who agree to maintain their existing lifestyle- dietary habits and skincare routine throughout the study duration.
- •Trial participants willing to comply with the protocol.
- •Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
排除标准
- •Trial Participants with known active skin infections.
- •Trial participants with severe skin redundancy.
- •Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
- •Trial participants having any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious/chronic medical illness or have undergone major surgery in the last year.
- •Trial participants who are pregnant or nursing (self-declared).
- •A known history or present condition of allergic response to any skincare or cosmetic treatments/procedures.
- •Trial participant who is an employee of the sponsor or the CRO.
结局指标
主要结局
Changes in body contour of the treatment site in comparison to baseline based on dermatological and instrumental evaluations
时间窗: Day 1 or 2, Day 30 and Day 90
次要结局
- Perceived changes of the treatment site in comparison to baseline based on patient reported outcome.(Day 1 or 2, Day 30 and Day 90)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd