Suspended

Upper Arm Treatment for Muscle Tone and Skin Appearance

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What is being tested

Sofwave and Pure Impact

Device
Who is being recruted

Connective Tissue Diseases+4

+ Cutis Laxa

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

From 25 to 70 Years
+41 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorSofwave Medical LTD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2024

Actual date on which the first participant was enrolled.

This study explores a new way to improve the appearance of loose skin and tone muscles in the upper arms. It involves a combination of two treatments, SofWave and Pure Impact. SofWave is typically known for its ability to tighten skin using ultrasound technology, while Pure Impact focuses on muscle toning. The study is looking at how well these treatments work together to address common concerns about skin laxity and muscle tone in the arms, which can be a significant issue for many people. Understanding the effectiveness of this treatment combination could lead to better options for those seeking to enhance their appearance in this area. Participants in the study will receive treatments on both of their upper arms. They will undergo one or two SofWave sessions and four Pure Impact treatments. The treatments may happen on the same day or on different days, depending on the schedule that works best. Pure Impact is always applied before SofWave if done on the same day. After completing all treatments, participants will have two follow-up visits, one approximately a month later and another around three months later. These visits help researchers assess the effectiveness of the treatment combination over time. The study's design ensures that participants are monitored regularly to check the safety and effectiveness of the treatments.

Official TitleSafety and Efficacy of Upper Arm Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance
NCT06724146
Principal SponsorSofwave Medical LTD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesCutis LaxaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesGenetic Diseases, Inborn

Criteria

9 inclusion criteria required to participate
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.

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32 exclusion criteria prevent from participating
BMI>30kg/m2

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tennessee Clinical Research Center

Nashville, United StatesOpen Tennessee Clinical Research Center in Google Maps
SuspendedOne Study Center
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