A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Unanticipated Adverse Device Effects (UADEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥22 years of age and ≤65 years of age.
- •Treatment area skin fold thickness > 1cm (measured by caliper).
- •Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
- •No weight change exceeding 5% of body weight in the preceding month.
- •Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
- •Subject has signed a written informed consent form
排除标准
- •Body Mass Index ≥ 46.2 as determined at screening.
- •Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
- •Prominent platysmal bands at rest which may interfere with assessment of treatment area.
- •Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
- •Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
- •Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.
- •Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months.
- •History of facial nerve paresis or paralysis (such as Bell's palsy).
- •History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
- •History of prior neck surgery, or prior surgery in the area of intended treatment.
- •Current infection in and adjacent to treatment area.
- •Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
- •Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- •History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- •Currently taking or has taken diet pills or weight control supplements within the past month.
- •Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
- •Active implanted device such as a pacemaker, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device.
- •Pregnant or intending to become pregnant in the next 6 months.
- •Lactating or has been lactating in the past 6 months.
- •Unable or unwilling to comply with the study requirements including remaining clean shaven for all study visits.
- •Currently enrolled in a clinical study of an unapproved investigational drug or device.
- •Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
结局指标
主要结局
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
时间窗: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
时间窗: Baseline, 12 weeks post radiofrequency treatment
Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
次要结局
- Percent Change From Baseline in Fat Layer Thickness(Baseline, 12 weeks post radiofrequency treatment)
- Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)(Baseline, 12 weeks post radiofrequency treatment)
- Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score(Baseline, 12 weeks post radiofrequency treatment)
- Number of Participants With Positive Response on Subject Satisfaction Questionnaire(Baseline, 12 Weeks Post Radiofrequency Treatment)