A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Reducing the Appearance of Cellulite Clinical Study Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Number of Subjects That Met the Individual Success Criteria
研究概览
简要总结
The purpose of this study is to determine whether the application of green diode low level laser light therapy is effective in reducing the appearance of cellulite in the thighs and buttocks.
详细描述
Cellulite is a common term used to describe superficial pockets of trapped fat, which causes uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In advanced stages of cellulite, heaviness and pain may occur.
Currently available treatments for cellulite have minimal to no demonstrable effect and some involve risky invasive procedures. Therefore, the potential advantages of the application of low level laser light therapy to reduce the appearance of cellulite over current treatment options include a risk free procedure that is non-invasive and pain free. Since low level laser light within the green spectrum has been proven to increase the synthesis of collagen, it is believed that its application may serve to decrease the appearance of cellulite by tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of the connective tissue responsible for the formation of cellulite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks
- •Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area
- •PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System
- •Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study
- •Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study
- •Willing and able to maintain regular medication schedule, as is medically feasible, during the study
排除标准
- •Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
- •P3 or P4 or P5 or P6 on the ASA Physical Status Classification System
- •Weight fluctuation greater than 10 pounds in the prior month
- •Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months
- •Prior surgical intervention to the treatment areas, for any reason
- •Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss
- •Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent
- •Any medical condition known to affect weight levels, cause bloating or swelling
- •Diagnosis of, and/or taking medication for, irritable bowel syndrome
- •Active infection, wound or other external trauma to the study treatment areas
- •Dermatitis or significant scarring in the study treatment areas
- •Medical, physical, or other contraindications for, or known sensitivity to, light therapy
- •Diabetes dependent on insulin or oral hypoglycemic medications
- •Known cardiovascular disease
- •Cardiac surgeries
- •History of deep venous thrombosis, arterial disease of the legs
- •Pregnant, breast feeding, or planning pregnancy prior to study end
- •Serious mental health illness or psychiatric hospitalization in past 2 years
- •Developmental disability or cognitive impairment that would impact study participation
- •Involved in litigation/receiving disability benefits related to the parameters of the study
- •Participation in research in the past 30 days
结局指标
主要结局
Number of Subjects That Met the Individual Success Criteria
时间窗: Baseline and 2 weeks
The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
次要结局
- Bilateral Upper Thigh Circumference Measurement(Baseline and 2 weeks)
- Change in Body Weight(Baseline and 2 weeks)
- Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.(Baseline and 2 weeks)
- Patient Satisfaction With Study Outcome(2 Weeks)