An Evaluation of the Effect of the Erchonia Corporation CFL Laser for Non-invasive Reduction of Submental Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators.
研究概览
简要总结
The purpose of this clinical study is to determine the effectiveness of the Erchonia® CFL (manufactured by Erchonia Corporation (the Company), in providing noninvasive fat reduction in the submental area.
详细描述
This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® CFL Laser in providing a noninvasive fat reduction in the submental area. Participants will receive 8 treatments over the course of 4 weeks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 65 years of age, inclusive.
- •Submental and submandibular skin fold thickness > 1cm (measured by caliper).
- •Subject agrees 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 agrees to abstain from partaking in any treatment to promote body contouring and/or weight loss during the course of study participation. Such treatments include, but are not limited to:
- •over-the-counter and/or prescription medications; dietary/herbal supplements and appetite suppressants.
- •weight loss programs/diet plans.
- •surgical procedures for sculpting of the chin fat pad/weight loss, e.g. submental lipectomy, lap bands.
- •Subject has signed a written informed consent form.
排除标准
- •Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
- •Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
- •Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
- •History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
- •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.
- •Currently enrolled in a clinical study of an unapproved investigational drug or device.
研究组 & 干预措施
Erchonia CFL Laser
405nm violet and 520nm green laser light therapy.
干预措施: Erchonia CFL Laser (Device)
结局指标
主要结局
Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators.
时间窗: 16 weeks (12 weeks post treatment)
Reviewers will be blinded to post-treatment (12 weeks post) vs. baseline untreated area. The order in which images will be presented will be randomized. 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 at least 2 of the 3 blinded evaluators correctly identifying a subject's pre-treatment and post-treatment (study endpoint) photographs for 80% or more of subjects.
Proportion of Accurately Identified Subject Pre- and Post-treatment Photographs by at Least Two of the Three Blinded Independent Evaluators.
时间窗: 16 weeks (12 weeks post treatment)
Reviewers will be blinded to post-treatment (12 weeks post) vs. baseline untreated area. The order in which images will be presented will be randomized. 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 at least 2 of the 3 blinded evaluators correctly identifying a subject's pre-treatment and post-treatment (study endpoint) photographs for 80% or more of subjects.
次要结局
- Change in Submental Skinfold Thickness (mm)(Baseline and 16 weeks (12 weeks post))
- Change in Submental Skinfold Thickness (mm)(Baseline and 16 weeks (12 weeks post))