NCT05355714

High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity

A Single Center, Blinded, Split-Body, Randomized Clinical Trial of High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Upper inner arms of enrolled subjects will be randomized to two (2) treatment groups: Sofwave and Ultherapy, with subjects receiving treatment with one device on their right side and the other on their left.

Detailed description

This is a prospective, single-center, blinded, split-body site, randomized, controlled clinical trial. The study will consist of 15 subjects who will be treated with Sofwave® on one upper medial arm and Ultherapy® to the contralateral upper medial arm for treatment of skin laxity. Upon enrollment and after a thorough review of the inclusion and exclusion criteria as well as obtaining written and informed consent, each subject will be randomized to have either their right upper inner arm or left upper inner arm treated with Sofwave®, and the contralateral arm will be treated with Ultherapy®. The treatment area is defined as the upper inner medial arm (Appendix A). This area, which abuts the axilla, was chosen as the treatment zone because it is primarily composed of skin on superficial fascia without excessive amounts of adipose tissue. Conversely, the posterior arm typically has extra adipose tissue which would confound the study's measurements At every visit, the subject's medical history and concomitant medications will be reviewed in detail and weight will be recorded. Additionally, at every treatment and follow-up visit, each subject will have standardized, high-resolution digital photographs taken (Appendix D). Prior to the treatment and at all follow-up visits, the blinded investigator will complete the Upper Inner Arm Visual Crepiness/Laxity Grading Scale, Point of Maximal Upper Arm Skin Laxity Diameter and Circumference Measurements, and skin firmness and elasticity measurements using a Cutometer® Dual MPA 580 (Courage+Khazaka electronic GmbH; Köln, Germany). Subjects may be treated on the same day that they are screened and provide informed consent. If applicable, a urine pregnancy test will be obtained prior to each treatment. Anesthesia will be provided per physician discretion; options include topical anesthetic (23% lidocaine/7% tetracaine) for 1-hour, oral valium, and/or nitrous oxide. Immediately before treatment, the upper arm treatment zones should be mapped and subsequently cleansed with Hibiclens® (chlorhexidine gluconate solution 4%; Mölnlycke Health Care AB; Gothenburg, Sweden). The arm randomized to receive Sofwave® will receive one treatment session during which the treatment area will receive 3-4 passes. The arm randomized to receive Ultherapy® will receive one treatment session during which the treatment area will receive 1 pass with the 4.0 MHz, 4.5-mm-depth transducer and a subsequent pass with the 7.0 MHz, 3.0-mm-depth transducer. Treatment start and end times will be recorded. After each treatment session and during all follow-up visits, the treating physician will evaluate the subjects for any procedure-related side effects and adverse events. The subjects will rate their pain. At each follow-up visit, a Physician Global Aesthetic Improvement Scale (PGAIS), Subject Global Aesthetic Improvement Scale (SGAIS), and subject satisfaction questionnaire will be completed.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Sofwave	High-Frequency Non-Focused Ultrasound Device
DEVICE	Ultherapy	Microfocused Ultrasound with Visualization

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-04-30
• Completion: 2023-10-01
• First posted: 2022-05-02
• Last updated: 2022-05-02

Locations

1 site across 1 country: United States