A Randomized Controlled Clinical Trial Evaluating the Efficacy of the Density Device in Skin Laxity among Trial Participants Undergoing GLP-1/GIP Therapy for Weight Loss.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- 1. Changes in skin toning or lifting, texture, fine Lines, nasolabial fold, visibility of pores, elasticity, Hyperpigmentation, Dermal density and epidermal thickness of the treatment sites (Face and neck) in comparison to baseline and control (group 2) based on dermatological and instrumental evaluations.
研究概览
简要总结
This clinical study is designed to evaluate the safety and efficacy of an investigational device for improving skin laxity in the face, neck, and inner upper arm regions over a 3-month period. After providing informed consent and meeting eligibility criteria, participants will undergo baseline assessments and treatment, followed by immediate post-procedure evaluation and telephonic follow-up within 48 hours. Follow-up visits will be conducted on Day 30 and Day 90 to assess treatment outcomes, safety, and participant satisfaction through repeat imaging, dermatological and instrumental assessments, and questionnaires. The study will conclude at Day 90 with final evaluations and completion of the exit formalities.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Trial participants receiving GLP-1/GIP therapy for weight loss.
- •Trial Participants who agree to maintain their existing lifestyle- dietary habits (i.e., no major changes in diet or exercise routines) and 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.
- •Trial participants who are willing to undergo the treatment procedure.
- •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, eczema, hypertrophic scarring, keloids, 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).
- •Received face and body contouring treatments (surgical or non-surgical) or skin-tightening procedures in the target area within the last 6 months.
- •Trial participants with severe skin redundancy or panniculus (hanging skin folds) requiring surgical intervention such as panniculectomy.
- •Implants or Devices: Metal implants, pacemakers, or defibrillators near the treatment area.
- •Trial Participants who are currently taking any medication other than GLP-1 or Any medication which, in the opinion of the investigator, may influence the interpretation of the study 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 have followed a crash diet or initiated a rigorous exercise program within the past 1 to 3 months prior to study enrollment.
- •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
1. Changes in skin toning or lifting, texture, fine Lines, nasolabial fold, visibility of pores, elasticity, Hyperpigmentation, Dermal density and epidermal thickness of the treatment sites (Face and neck) in comparison to baseline and control (group 2) based on dermatological and instrumental evaluations.
时间窗: Day 1 or 2, Day 30 and Day 90
2. Perceived changes of the treatment sites in comparison to baseline and control (group 2) based on patient reported outcomes.
时间窗: Day 1 or 2, Day 30 and Day 90
次要结局
- 1. Changes in skin toning or lifting, texture, elasticity, Dermal density and epidermal thickness of the treatment site (Inner Upper arm region) in comparison to baseline and control group (group 2) based on dermatological and instrumental evaluations.(2. Perceived changes of the treatment site (Inner Upper arm region) in comparison to baseline and control group (group 2) based on patient reported outcome.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd