Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: a Randomized, Intra-patient, Left-right Arm, Non-inferiority Clinical Trial Comparing Vaser to Blunt Dissection for Site Preparation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in baseline area compared to 9 months post procedure from digital photographs.
研究概览
简要总结
The Renuvion/J-plasma cold atmospheric plasma device has been in clinical use in aesthetics since its approval by the FDA in 2012, but no rigorous clinical trials have been published to quantify the effect of the skin tightening in any body area. In current clinical practice, the device is frequently used in conjunction with liposuction and both blunt and ultrasound assisted dissection cannulas are utilized. There is some thought that ultrasound assisted dissection may impart some tissue warming and skin tightening effects, but these effects are anecdotal at this time and not rigorously scientifically tested. Our study is designed to address these practice gaps by quantifying the improvement in skin laxity by objective measurements and comparing results obtained between blunt and ultrasound assisted dissection techniques without concurrent liposuction.
This study will use a single-blind, prospective, right-left sided comparator design to assess the effect of the Renuvion/J-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design. This study will be a prospective, single-blind (assessor), randomized right-left sided, non-inferiority clinical trial.
Procedures:
This is a randomized, right-left arm, single blinded, prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the Renuvion/J-plasma cold atmospheric plasma (CAP) device while quantitatively evaluating the efficacy of the Renuvion device.
A total of 15 patients will be enrolled. Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments. The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the Renuvion/J-Plasma procedure.
详细描述
The Renuvion/J-plasma cold atmospheric plasma device has been in clinical use in aesthetics since its approval by the FDA in 2012, but no rigorous clinical trials have been published to quantify the effect of the skin tightening in any body area. In current clinical practice, the device is frequently used in conjunction with liposuction and both blunt and ultrasound assisted dissection cannulas are utilized. There is some thought that ultrasound assisted dissection may impart some tissue warming and skin tightening effects, but these effects are anecdotal at this time and not rigorously scientifically tested. Our study is designed to address these practice gaps by quantifying the improvement in skin laxity by objective measurements and comparing results obtained between blunt and ultrasound assisted dissection techniques without concurrent liposuction.
Study Design:
This study will use a single-blind, prospective, right-left sided comparator design to assess the effect of the Renuvion/J-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design. This study will be a prospective, single-blind (assessor), randomized right-left sided, non-inferiority clinical trial.
Bliniding:
To blind the study, the sub-investigator/operator will use an internet-based random number generator to assign the right arm to blunt dissection (odd numbers) or ultrasound-assisted dissection (zero and even numbers). Due to the nature of the procedure, it will be impossible to blind the operator and the patient to site preparation technique. The assessors and coordinators will remain blinded to the treatment assignment throughout the study. Measurements and photographs will not be labeled regarding which site preparation method was used. A patient specific paper chart will have treatment assignments, which will minimize the potential for inadvertent unblinding and allow for unblinding in the event unblinding becomes necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded assessor will review the results to determine if there is a significant difference in the two techniques by looking at the photos once the study is over.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to give informed written consent
- •BMI < 25
- •Age of at least 18 and not greater than 75 years old
- •Male or Female
- •Ability to undergo procedure
- •Stable weight for 6 months
- •2 cm to 6 cm of upper arm ptosis
- •Less than or equal to 1 cm of skin pinch thickness in area to be treated.
排除标准
- •Prior liposuction to the proposed treatment areas
- •Connective tissue disease
- •History of Keloidal scarring
- •Nursing/pregnant
- •Using systemic steroids or immunosuppressants
- •Current smoking
- •Body dysmorphic disorder
- •Allergy or intolerance to tumescent anesthesia
- •Prior significant trauma or scarring to the upper arms
- •Lymphedema of the upper extremities
- •Significant asymmetry in diameter or laxity of upper arms
结局指标
主要结局
Change in baseline area compared to 9 months post procedure from digital photographs.
时间窗: 9 months
The efficacy will be measured using the change in area calculated from standardized digital photographic overlays using the sagittal view between baseline and 9-months post-procedure.
Change in vertical distance compared to 9 months post procedure from digital photographs
时间窗: 9 months
The efficacy will be measured using the change in vertical distance calculated from standardized digital photographic overlays using the sagittal view between baseline and 9-months post-procedure.
次要结局
- Change in Body-Q scores from baseline to 9 months(9 months)
- Change in baseline area compared to 1 months post procedure from digital photographs.(1 month)
- Change in arm circumference from baseline to 9 months.(9 months)
- Change in baseline area compared to 3 months post procedure from digital photographs.(3 months)
- Change in vertical distance compared to 3 months post procedure from digital photographs.(3 months)
- Change in baseline vertical distance compared to 1 months post procedure from digital photographs.(1 month)
- Change in Skindex-16 scores from baseline to 9 months(9 months)
研究者
David Smart
Assistant Professor, Dermatology, Principal Investigator
University of Utah