Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants With Unanticipated Adverse Device Effects (UADE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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).
- •Sufficient treatment area requiring at least 2 cooling cycles.
- •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
- •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, radiofrequency or laser procedures, or chemical peels in the treatment area (below the mandible) within the past 6 months.
- •Botulinum toxin 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, defibrillator, or drug delivery system.
- •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.
- •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 (UADE)
时间窗: Enrollment through study completion, an average of 6 months.
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers
时间窗: Baseline through 12 weeks post second treatment.
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment (baseline) and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which photographs will be presented will be randomized; for each subject placement of the baseline and pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.
次要结局
- Change in Fat Layer in the Treated Jawline Area(Baseline and 12 weeks post-final treatment.)
- Overall Satisfaction With the Treatment(12-week post-final treatment follow-up visit)