Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance

NCT06724146 | Active Not Recruiting FDA Device

• 1 other identifier: Sofwave25
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Lax and Muscle Strength

Keywords

Upper arm; skin laxity; muscle tone; muscle strength; muscle firm

Outcome Measures

Primary Outcomes (1)

• Improvement in the appearance of lax skin

  Rate of improvement in the appearance of lax skin and in the strength and tone muscles in the upper arms following Sofwave and Pure Impact combined treatment based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.

  3 months post treatment follow-up visit

Study Arms (1)

Lax Tissue and Muscles

EXPERIMENTAL

Device: Sofwave and Pure Impact

Interventions

Sofwave and Pure Impact 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. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.

Also known as: SUPERB

Lax Tissue and Muscles

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 25 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 treatments on upper arms for skin lax and for strength and tone muscles.
• 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 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 and Pure Impact treatments.
• 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, open wounds etc.) in the treatment area.
• Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.
• Known allergy to lidocaine or epinephrine.
• Active malignancy or history of malignancy in the past 5 years.
• Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (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 a 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.
• BMI\>30kg/m2
• Non-stable weight nominally ±5% in the past month.
• Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Cutis Laxa

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

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: December 4, 2024
• First Posted: December 9, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

US (1)