Treatment for Lifting Upper Arm Lax Skin

NCT05358327 | Completed FDA Device

• 1 other identifier: Sofwave07
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Conditions

Lax Skin

Keywords

upper arms, lax skin

Outcome Measures

Primary Outcomes (1)

• Rate of improvement of upper arms lax skin

  following Sofwave treatment as evaluated by independent masked reviewers

  1 year

Study Arms (1)

Upper Arm

EXPERIMENTAL

Device: Sofwave

Interventions

Sofwave DEVICE

The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Also known as: SUPERB

Upper Arm

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects \> 35 years of age and \< 70 years of age.
• Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
• Desire to undergo upper arms skin lax lifting treatments.
• Subject has clearly visible lax skin on the upper arm, which in the investigator's opinion, may benefit from the treatment.
• Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
• Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
• Willing to have research photos taken of treatment areas.
• Subject agrees not to undergo any other upper arm skin lax treatments for a period of 3 months following Sofwave treatment.
• Able to understand and provide written Informed Consent.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
• Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.).
• History of Epileptic seizures.
• Known allergy to lidocaine or epinephrine or antibiotics.
• Active malignancy or history of malignancy in the past 5 years.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
• History of significant lymphatic drainage problems.
• Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
• History of chronic drug or alcohol abuse.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• BMI\>=30kg/m2

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (4)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Advanced Dermatology

Lincolnshire, Illinois, 60069, United States

Location

Laser & Skin Surgery Center of New York®

New York, New York, 10016, United States

Location

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

MeSH Terms

Conditions

Cutis Laxa; Rhabdomyosarcoma, Alveolar

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Ruthie Amir, MD

  CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 3, 2022
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-03

Locations

US (4)