Sofwave vs Ultherapy for Loose Skin

Overseen By Sherif Mikhail, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Must not be taking: Immunosuppressants

Disqualifiers: Skin conditions, Vascular disorders, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Sofwave (Focused Ultrasound Stimulator System for Aesthetic Use) and Ultherapy, to evaluate their effectiveness in improving loose skin on the upper inner arms. The researchers aim to determine which treatment is superior by applying each to a different arm. Suitable candidates for this trial have moderate to severe loose skin on their upper inner arms that improves when stretched. Participants must have maintained a stable body weight for at least six months and agree to follow specific guidelines, such as avoiding tanning, during the study. As an unphased trial, this study allows participants to explore innovative treatments for aesthetic improvement.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on an immunosuppressant or have an autoimmune condition, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Sofwave is a non-invasive treatment approved by the FDA for improving loose skin, confirming its safety. It uses ultrasound waves to lift and tone the skin without surgery. Sofwave is usually well-tolerated, and clinical studies have found no major safety issues.

Studies have also shown that Ultherapy is FDA-approved for lifting and tightening skin on areas like the neck and chin. While generally safe, Ultherapy can cause side effects, such as burns and nerve injury, if not performed correctly, especially by someone without experience.

Both treatments have undergone FDA review, indicating they are safe when used properly. However, trained professionals should always perform these treatments to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Sofwave and Ultherapy for treating upper inner arm skin laxity because they offer non-invasive solutions using high-intensity ultrasound technology. Unlike traditional surgical procedures like arm lifts, which can be invasive and require significant recovery time, Sofwave and Ultherapy provide a less invasive option with minimal downtime. Sofwave utilizes parallel beam technology, delivering ultrasound energy to the skin's deeper layers to stimulate collagen production, while Ultherapy employs micro-focused ultrasound to lift and tighten the skin. These methods promise effective results without the risks and recovery associated with surgery, making them appealing alternatives for those seeking skin-tightening solutions.

What evidence suggests that this trial's treatments could be effective for aesthetic use on the upper inner arms?

This trial will compare Sofwave and Ultherapy, two non-invasive ultrasound treatments for skin tightening. Research has shown that Sofwave effectively tightens skin by increasing collagen and elastin production, proteins that keep skin firm and stretchy. The FDA has approved Sofwave for reducing facial lines and wrinkles, and it may also help with loose skin in other areas, like the upper arms.

Ultherapy, another treatment option in this trial, also uses ultrasound technology and is FDA-approved to lift and tighten skin on the face and neck. Studies have found that about 93% of patients noticed firmer skin within six months, with results lasting up to two to three years. Both treatments are non-surgical and have shown positive results in lifting and firming the skin. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Must be willing to give and sign an informed consent form and photographic release form

Male or female subjects > 35 years of age and < 70 years of age

Subjects in good general health based on investigator's judgment and medical history

Exclusion Criteria

You have received any experimental treatment for loose or wrinkled skin on your upper arms within the past year.

You are currently taking medication that weakens your immune system or have an autoimmune disease.

You cannot use any creams, cosmetics, or home remedies to improve or treat loose skin for four weeks before starting the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive treatment with Sofwave® on one arm and Ultherapy® on the other arm for skin laxity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of skin elasticity, firmness, and aesthetic improvement

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sofwave
• Ultherapy

How Is the Trial Designed?

Group I: Ultherapy Experimental Treatment 1 Intervention

Group II: Sofwave Experimental Treatment 1 Intervention

Sofwave is already approved in United States, European Union for the following indications:

Approved in United States as Sofwave System for:

• Reducing fine lines and wrinkles
• Tightening lax skin under the chin
• Lifting the eyebrows
• Lifting sagging neck tissue
• Temporarily reducing the appearance of cellulite

Approved in European Union as Sofwave System for:

• Improvement in facial lines and wrinkles
• Short-term improvement in the appearance of cellulite

Who Is Running the Clinical Trial?

Goldman, Butterwick, Fitzpatrick and Groff

Lead Sponsor

Trials

32

Recruited

660+

Sofwave Medical LTD

Industry Sponsor

Trials

11

Recruited

640+

Published Research Related to This Trial

Ultrasound energy from devices like Ulthera and Sofwave effectively induces collagen remodeling in the skin, leading to noticeable lifting and tightening effects, particularly in areas like the eyebrows, neck, and submental region.

Both systems are FDA-approved, have high patient satisfaction rates, minimal recovery time, and an excellent safety profile, making them effective nonsurgical options for facial rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Therapy for the Skin. Wong, A., Lowery, AS., Bloom, JD.[2023]

In a phase 1 study involving 15 participants, intense ultrasound treatment for facial and neck tissues was found to be safe, with no significant adverse effects reported and only mild discomfort experienced by patients.

Histological analysis showed that the treatment created consistent thermal injury zones in the dermis without damaging the epidermis, indicating a targeted and effective approach for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Gliklich, RE., White, WM., Slayton, MH., et al.[2012]

High-intensity focused ultrasound (HIFU) transducers operating at 20 MHz can precisely target specific layers of human skin, with a focal diameter of 80.6 µm and a depth of focus of 490 µm, making them suitable for dermatological treatments.

The study utilized advanced modeling techniques and experimental measurements to confirm that the size and shape of the ultrasound pressure fields can be controlled by the transducer's frequency and f-number, enhancing the efficacy of targeted skin treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strongly Focused HIFU Transducers With Simultaneous Optical Observation for Treatment of Skin at 20 MHz. Zawada, T., Bove, T.[2022]

The study validated the safety and effectiveness of a noninvasive focused ultrasound technology for body contouring, showing that it can cause fat cell lysis without damaging surrounding tissues, based on experiments with 14 porcine subjects.

Real-time imaging techniques confirmed that the ultrasound energy was precisely delivered to the targeted area, ensuring that there were no adverse effects on blood vessels, nerves, or skin during the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of nonthermal focused ultrasound for noninvasive selective fat cell disruption (lysis): technical and preclinical assessment. Brown, SA., Greenbaum, L., Shtukmaster, S., et al.[2022]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

Citations

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Sofwave™ - The Future of Non-Invasive Skin Regeneration

Sofwave offers non-invasive, clinically proven, and FDA-cleared ultrasound and EMS solutions to improve skin laxity, lift, and tone.

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K240687 - Janice Hogan - accessdata.fda.gov

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The Use of Ultrasound in Aesthetics: Review and Update

In order to counteract many of the clinical effects of aging, the goal is to increase the formation and amount of new collagen and elastin in the skin, ...

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The Efficacy and Safety of a Single Treatment of High ...

Synchronous US parallel beam technology appears to be a promising and safe option for treating acne scars in Asian patients.

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accessdata.fda.gov

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August 7, 2024 Sofwave Medical Ltd. Ruthie Amir Chief ...

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the ...

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf25/K250146.pdf

April 18, 2025 Sofwave Medical Ltd. Janice Hogan Partner ...

The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the ...

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federalregister.gov

federalregister.gov/documents/2011/07/20/2011-18278/medical-devices-general-and-plastic-surgery-devices-classification-of-the-focused-ultrasound

Classification of the Focused Ultrasound Stimulator System ...

The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls) ...

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sofwave.com

sofwave.com/safety-information

Safety Information

Sofwave's commited to patient safety. Explore clinical data, FDA clearances, and guidelines ensuring effective, non-invasive aesthetic treatments.

9.

fda.gov

fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/focused-ultrasound-stimulator-system-aesthetic-use-class-ii-special-controls-guidance-industry-and

Focused Ultrasound Stimulator System for Aesthetic Use

This guidance document was developed as a special control guidance to support the classification of the focused ultrasound stimulator system for aesthetic use ...