Sofwave for Cellulite

No longer recruiting at 4 trial locations

Overseen By Anne M. Chapas, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Sofwave Medical LTD

Must not be taking: Anticoagulants, Immunosuppressants, Psychiatric medications, others

Disqualifiers: Pregnancy, BMI >= 30, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Sofwave, a focused ultrasound device, to determine its effectiveness in reducing cellulite in the upper thigh and buttock areas. The goal is to assess the treatment's efficacy and safety for participants. Women with visible cellulite in these areas, who have maintained a stable weight and seek treatment, might be suitable candidates for this study. Participants should not have undergone recent cellulite treatments and must be willing to follow study guidelines, including allowing photos of the treated areas.

As an unphased trial, this study provides participants the opportunity to explore a new option for cellulite reduction.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulant medication, psychiatric medication, or immunosuppressive medications, you may not be eligible to participate.

What prior data suggests that the Sofwave device is safe for treating cellulite?

Research shows that Sofwave is a non-invasive treatment using ultrasound technology. The FDA has approved it to improve loose skin and appearance, including temporary cellulite improvement. This approval confirms it has passed safety checks for these uses.

Studies have found that patients generally tolerate Sofwave well. As a non-invasive treatment, it doesn't require surgery or a long recovery time. Available data reports no major serious side effects or problems, making it a promising option for those seeking to enhance their skin's appearance without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sofwave is unique because it uses ultrasound technology to target cellulite, which is different from most standard treatments like creams, massages, or laser therapy. Unlike traditional methods that often focus on topical or surface-level changes, Sofwave delivers energy deep into the skin to stimulate collagen production, aiming to improve skin texture and reduce cellulite appearance. Researchers are excited about Sofwave because it offers a non-invasive option that could potentially provide quicker and more visible results without the need for surgery or lengthy recovery times.

What evidence suggests that the Sofwave system is effective for cellulite?

Research has shown that Sofwave, a non-invasive ultrasound treatment, produces promising results in reducing the appearance of cellulite. In a clinical study, independent reviewers rated 93% of treated areas as "improved" or "very much improved." The device uses strong ultrasound waves to target and tighten loose skin, making it appear firmer and smoother. Sofwave is FDA-cleared, indicating it has been reviewed and approved for safety and effectiveness in short-term cellulite improvement. These findings suggest that Sofwave could effectively reduce cellulite. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject agrees not to undergo any other cellulite treatments for a period of 3 months following SofWave treatment

You want to get rid of cellulite on your upper thighs and/or buttocks.

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

Exclusion Criteria

You have a history of skin disorders that affect the collagen or blood vessels in your body.

Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding

You smoke a lot, at least 25 cigarettes a day, or have smoked heavily in the last 10 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 treatments using the SofWave System with the Form applicator, 4 ± 2 weeks apart

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sofwave

How Is the Trial Designed?

Group I: Cellulite 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?

Sofwave Medical LTD

Lead Sponsor

Trials

11

Recruited

640+

Published Research Related to This Trial

In a clinical trial with 164 participants, the Contour I device demonstrated safety and efficacy for noninvasive body contouring, achieving an average reduction of about 2 cm in circumference and 2.9 mm in fat thickness after a single treatment.

The results showed that most of the fat reduction occurred within 2 weeks and was maintained over a 12-week period, with no significant safety concerns reported, as all adverse events were mild and resolved quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Teitelbaum, SA., Burns, JL., Kubota, J., et al.[2021]

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]

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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223237.pdf

December 16, 2022 Sofwave Medical Ltd. Janice Hogan ... The SofWave. System is also intended for short-term improvement in the appearance of cellulite. The SofWave System is indicated for use as a non ...

2. sofwave.com sofwave.com/

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.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240687.pdf

K240687 - Janice Hogan - accessdata.fda.gov The SofWave System is also intended for short-term improvement in the appearance of cellulite. Device Technology. High intensity, non-focused.

4. sofwave.com sofwave.com/providers/body

Sofwave Body Treatments for Non-Invasive Lifting and ... The clinical study showed that 93% of treated arms were “improved” or “very much improved” in appearance, as rated by the blinded reviewers using the Global ...

5. withpower.com withpower.com/trial/phase-cutis-laxa-3-2022-430b6

High Intensity Ultrasound for the Treatment of Upper Inner ... This trial compares two treatments, Sofwave® and Ultherapy®, for tightening loose skin on the upper inner arms. Sofwave® uses sound waves, while Ultherapy® ...

6. 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.

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

April 18, 2025 Sofwave Medical Ltd. Janice Hogan Partner ... The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232455.pdf

December 14, 2023 Sofwave Medical Ltd. Janice Hogan ... The. SofWave System is also intended for short-term improvement in the appearance of cellulite. The SofWave System is indicated for use as a non ...