An Evaluation of the Erchonia Corporation GVS Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity on the Abdominal Region
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 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® GVS in improving the appearance of skin laxity on the abdominal region.
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® GVS Laser in improving the appearance of skin laxity on the abdominal region. 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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed a written informed consent form.
- •Male or female 22 to 70 years of age, inclusive.
- •Desire to undergo treatment for skin laxity of the abdomen.
- •Subject's score on the skin laxity scale for skin on the abdomen is 1 (mild) or 2 (moderate).
- •Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet, exercise or medication routine during the course of the study.
- •Subject agrees to refrain from taking any medication(s) or supplements(s), whether prescription or OTC, or undergo any procedures indicated for weight loss, or for fat reduction or improving the appearance of the skin in the abdominal area (e.g. liposuction, ultrasound therapy) for the duration of participation in the clinical study.
- •Willing to have research photos taken of treatment areas.
- •Understands, and is able and willing to comply with all study visits, treatments and evaluations schedules and requirements.
- •Females are at least 9 months post-partum.
- •Females are post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study and agree to continue to do so for the duration of study participation.
排除标准
- •Skin laxity resulting from genetic disorders, including but not limited to Ehlers-Danlos Syndrome.
- •History of undergoing a fat reduction procedure (e.g., liposuction, bariatric surgery, abdominoplasty).
- •Botulinum toxin or other aesthetic drug injections within the abdomen area within the past 6 months.
- •History of any major prior surgery in the abdominal area
- •Implanted medical prostheses (such as clips, pins or plates) in or adjacent to the area of intended treatment.
- •Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- •Any clinical and significant dermatological skin condition(s) in the intended abdominal treatment area, such as skin infections or rashes, extensive scarring, psoriasis, etc..
- •Tattoo or former tattoo at the treatment area.
- •Current moderate to heavy tobacco use, defined as smoking 10 or more cigarettes per day (or equivalent use of other nicotine-containing products such as cigars, pipes, chewing tobacco, or e-cigarettes) within the past 6 months
- •History of chronic drug or alcohol abuse.
- •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 GVS Laser
405nm violet and 520nm green laser light therapy.
干预措施: Erchonia GVS 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: 12 weeks
Reviewers will be blinded to post-treatment (12 weeks) 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
- Global Aesthetic Improvement Scale- Investigator Assessed(12 weeks)