Sofwave for Cellulite

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a device called the SofWave System to treat patients' upper thighs and/or buttocks. The device sends energy into the skin to improve its appearance or health.

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 data supports the effectiveness of the Sofwave treatment for cellulite?

Research shows that ultrasound technology, like the one used in Sofwave, can help reduce cellulite by using sound waves to heat and renew skin, making it smoother. Other studies have shown that similar ultrasound treatments are safe and effective for body contouring and reducing unwanted fat. ^{1 2 3 4 5}

Is Sofwave treatment safe for humans?

Sofwave, which uses ultrasound technology, is generally safe for humans when used correctly. Most side effects are mild and temporary, like tenderness and redness, and serious issues are rare and often due to improper use. ^{1 6 7 8 9}

How does the Sofwave treatment for cellulite differ from other treatments?

Sofwave uses focused ultrasound technology to target cellulite by heating tissue, which can help renew skin elasticity and improve body contouring. This method is unique because it enhances the absorption of topical products and promotes skin tightening through thermal effects, unlike other treatments that may rely on mechanical or shockwave methods. ^{1 2 3 10 11}

Eligibility Criteria

Inclusion Criteria

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

Healthy female subjects > 18 years of age and < 60 years of age

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

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

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)

Treatment Details

Interventions

• Sofwave

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The effect of topical caffeine on the morphology of swine hypodermis as measured by ultrasound. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of the Use of Ultrasound for Skin Tightening, Body Contouring, and Cellulite Reduction in Dermatology. [2018]

4. United States 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. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[The efficacy and safety study of JCS-01 non-invasive focused ultrasound fat reduction machine]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Ultrasound Therapy for the Skin. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Characterization of nonthermal focused ultrasound for noninvasive selective fat cell disruption (lysis): technical and preclinical assessment. [2022]

10. Egypt pubmed.ncbi.nlm.nih.gov

Effectiveness of the Electromagnetic Shock Wave Therapy in the Treatment of Cellulite. [2020]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Can cellulite be treated with low-energy extracorporeal shock wave therapy? [2021]