NCT04902599

Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: Dissection Technique Comparison

Terminated NA Last updated 22 September 2022

What this trial tests

NA trial testing Renuvion/j-Plasma procedure using blunt dissection technique in Subdermal Skin Tightening in 3 participants. Terminated before completion.

Timeline

17 September 2020

Primary endpoint
30 August 2022

30 August 2022

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	3
Start date	17 September 2020
Primary completion	30 August 2022
Estimated completion	30 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Renuvion/j-Plasma procedure using blunt dissection technique
• Renuvion/j-Plasma procedure using ultrasound-guided dissection technique

Conditions studied

• Subdermal Skin Tightening — all drugs for Subdermal Skin Tightening →

Sponsor

University of Utah

Who can join

Adults 18 to 75, any sex, with Subdermal Skin Tightening. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.