Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: Dissection Technique Comparison
Stopped early · Not applicable
Conditions studied: Subdermal Skin Tightening
In brief
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.
Key facts
- Study ID
- NCT04902599
- Run by
- University of Utah
- People needed
- 3
- Starts
- 2020-09-17
- Expected to finish
- 2022-08-30
- Last updated by the study team
- 2022-09-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Utah MidValley Dermatology — Murray, Utah, United States
Full record on ClinicalTrials.gov
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