A clinical study to evaluate the efficacy of the Density device for periorbital rejuvenation over 3-months period.
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Change in fine skin toning, fine lines & wrinkles on periorbital region as evaluated by dermatological assessments at all timepoints compared to baseline.
研究概览
简要总结
This clinical study is a baseline-controlled, efficacy and safety evaluation of the Density device for periorbital rejuvenation conducted over approximately 3 months. Following informed consent and screening (Visit 1), eligible participants will undergo baseline assessments, the study procedure, and immediate post-procedure evaluations (Visit 2). Imaging, dermatological, and instrumental assessments will be performed to document baseline skin condition, followed by the device procedure conducted as per protocol. Participants will be monitored for any adverse events and receive post-care instructions, with a telephonic follow-up within 48 hours. Subsequent follow-up visits will be conducted on Day 30 (Visit 3) and Day 90 (Visit 4) to assess treatment efficacy, participant satisfaction, and safety outcomes through repeat imaging, dermatological and instrumental assessments, and questionnaires. The final visit (Day 90) will conclude the study with end-of-participation documentation.
研究设计
- 研究类型
- Pms
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male & Female trial participants aged between 30-60 years (both ages inclusive).
- •Participants who agree to maintain their existing skincare routine throughout the study duration.
- •Trial participants with Skin toning or lifting score of 2-5 as evaluated by the dermatological visual assessment scale.
- •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.
- •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, open wounds, dermatitis, or eczema, hypertrophic scarring, keloids and connective tissue disorders (self-declared) or dormant dermatological conditions at the treatment site (e.g., psoriasis, rosacea, seborrheic dermatitis, vitiligo, or disorders of hyperpigmentation or hypopigmentation).
- •Trial participants with recent treatment / Procedures on the test area (surgical or nonsurgical) or skin-tightening procedures in the target area within the last 6 months.
- •Trial participants having any implants or device near the treatment area.
- •Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
- •Trial participants who have participated in a similar clinical study 4 weeks before this study.
- •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
1. Change in fine skin toning, fine lines & wrinkles on periorbital region as evaluated by dermatological assessments at all timepoints compared to baseline.
时间窗: Day 1 or 2, day 30 and day90
2. Change in skin texture, fine lines & pigmentation on periorbital region by Antera 3D at all timepoints compared to baseline.
时间窗: Day 1 or 2, day 30 and day90
次要结局
- 1. Change in melanosis, Skin texture, puffiness on periorbital region as evaluated by dermatological assessments at all timepoints compared to baseline(2. Perceived changes in periorbital rejuvenation from baseline, as evaluated through participant feedback questionnaires.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd