NCT06192550已完成不适用
Functional Usability and Feasibility Testing of the Profound Matrix™ System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 9
- 主要终点
- Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
研究概览
简要总结
This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male or Female
- •Age 18 to 75
- •Subjects seeking treatment for facial, abdominal, or back wrinkles reduction, skin texture improvement and/or acne scars appearance improvement and willing to undergo RF treatments for improvement
- •Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
- •Willingness to provide signed, informed consent to participate in the study
- •Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- •Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
- •Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment
- •Current skin cancers in the treatment area or history of melanoma
- •History of current cancer and subject has undergone chemotherapy within the last 12 months
- •Severe concurrent conditions, such as cardiac disorders
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
- •Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
- •Poorly controlled endocrine disorders such as diabetes
- •Active skin condition in the treatment area such as sores, psoriasis, eczema, or rash, open wounds, and severe active inflammatory acne.
- •History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very dry and fragile skin
- •History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitis disorders
- •Known allergy to lidocaine, tetracaine, Xylocaine, epinephrine or ProNox (nitrous oxide (laughing gas))
- •Patients on systemic corticosteroid therapy in past six months
- •Is taking medication(s) for which sunlight is a contraindication
- •Tattoos or permanent makeup in the intended treatment area
- •Excessively tanned skin
- •Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
- •Subject has hair and is unwilling to have hair removed from the treatment area
- •Subjects has undergone facelift in the last 12 months
- •Subject has undergone aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months) within the intended to treat area
- •Subject has undergone Botox in the treatment area within the last 3 months
- •Subject has non-permanent filler in the last 3 months within the intended to treat area
- •Subject has permanent filler (e.g. silicone) within the intended to treat area
- •Subject has absorbable facial threads within the last 2 years within the intended to treat area
- •Subject has non-absorbable facial threads within the intended to treat area aa. Subject is using a topical in the treatment area that the Investigator's deems the subject unsuitable for the study.
- •bb. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements
结局指标
主要结局
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
时间窗: 3 months post final treatment
Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by investigator at study endpoint
次要结局
- Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance(3 months post final treatment)
研究者
研究点 (9)
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