A clinical study to evaluate the efficacy of the Density device for facial rejuvenation in female trial participants over 3-months period.
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in fine Lines, wrinkles, Skin firmness/laxity, and other parameters on face as evaluated by dermatological and instrumental assessments at all timepoints compared to baseline.
研究概览
简要总结
This study aims to evaluate the efficacy of the Density device over a three-month period, with a specific focus on outcomes related to facial rejuvenation involving both dermatological assessments and instrumental measurements, alongside patient-reported outcomes, to comprehensively assess treatment performance. Female participants aged 25 to 60 years will be enrolled, and a total of four visits will be scheduled for each participant. Visit 1 for screening, visit 2 for baseline, procedure and immediate post procedure assessment, and follow-up assessment visits on day 30 (visit 3) and day 90 (visit 4). Safety will be monitored throughout the study to identify any adverse effects.
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
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.
- •Trial participants with fine lines, wrinkles & skin laxity.
- •Participants who agree to maintain their existing skincare routine throughout the study duration.
- •Trial participants able to read, speak, write and understand the informed consent form and provide consent for study procedures.
- •Trial participants who are willing to have standardized clinical photographs taken of the treatment areas at all study visits for documentation and evaluation purposes.
排除标准
- •Trial participants with known active skin infections.
- •Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
- •Trial participants who are pregnant or nursing (self-declared).
- •A known history of allergic response to any skincare or cosmetic treatment/ procedures.
- •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 participant who is an employee of the sponsor or the CRO.
结局指标
主要结局
Change in fine Lines, wrinkles, Skin firmness/laxity, and other parameters on face as evaluated by dermatological and instrumental assessments at all timepoints compared to baseline.
时间窗: Day 1 or 2, Day 30, Day 90
次要结局
- Perceived changes in facial rejuvenation from baseline, as evaluated through participant feedback questionnaires(Day 1 or 2, Day 30, Day 90)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd