Status:

TERMINATED

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

Lead Sponsor:

University of Utah

Conditions:

Subdermal Skin Tightening

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

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 e...

Detailed 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 e...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

September 17 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 30 2022

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT04902599

Start Date

September 17 2020

End Date

August 30 2022

Last Update

September 22 2022

Active Locations (1)

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1

University of Utah MidValley Dermatology

Murray, Utah, United States, 84107