Sofwave for Loose Skin

Recruiting at 1 trial location

Overseen By Ruthie Amir, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sofwave Medical LTD

Must not be taking: Isotretinoin, Retinoids, Anti-coagulants, others

Disqualifiers: Pregnancy, Infections, Smoking, 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: 2

Duration: 2-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test Sofwave, a treatment designed to tighten loose skin on the face, neck, and eyebrow area and improve the appearance of facial wrinkles. The goal is to evaluate Sofwave's effectiveness in lifting and firming these areas. All participants will receive the treatment, and experts will assess their results. Suitable candidates are non-smokers aged 35-80 who wish to improve sagging skin and have maintained a stable weight for the past 12 weeks. Participants should not have had recent facial cosmetic treatments or any active skin conditions. As an unphased trial, this study offers participants the chance to experience a promising treatment and contribute to valuable research on its effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken Isotretinoin or other oral retinoids in the past 6 months, or anti-platelet or anti-coagulant medications in the past 2 weeks.

What prior data suggests that the Sofwave System is safe for treating loose skin?

Research has shown that Sofwave, a non-invasive treatment for tightening skin, is safe for use. The FDA has cleared Sofwave, indicating it has passed safety tests for reducing facial lines and wrinkles. Studies have found that this treatment uses ultrasound technology, which is generally well-tolerated and effective for improving skin. No major reports of harmful effects have emerged from using Sofwave, making it a promising option for those seeking to improve skin firmness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sofwave is unique because it uses advanced ultrasound technology to target loose skin. Unlike traditional treatments like facelifts or laser therapies, which can be invasive or require downtime, Sofwave delivers precise energy to the skin's deeper layers without affecting the surface. This non-invasive approach stimulates collagen production, potentially leading to firmer skin with minimal recovery time. Researchers are excited about Sofwave because it offers a promising, less disruptive option for those looking to address skin laxity.

What evidence suggests that the Sofwave System is effective for treating loose skin?

Research has shown that Sofwave, the treatment under study in this trial, effectively improves loose skin. Studies have found that it uses ultrasound energy to tighten and lift the skin without surgery. The FDA has approved this treatment for use on various body areas, including the upper arms, where it helps with sagging skin. Patients have noticed improvements in their skin's appearance and texture. Sofwave creates heat deep in the skin, boosting collagen production and leading to firmer skin. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 35-80 who want to improve facial wrinkles and lift lax skin, without undergoing other cosmetic treatments for 3 months post-trial. Participants must be non-smokers with stable weight, not pregnant or breastfeeding, and using reliable birth control if applicable.

Inclusion Criteria

I agree not to have any facial cosmetic treatments for 3 months after my last SofWave treatment.

I want to improve sagging skin on my face, neck, under my chin, lift my eyebrows, or reduce facial wrinkles.

I have been using birth control for at least 3 months.

Exclusion Criteria

I have a skin condition that could affect healing.

I have severe acne or have used Accutane in the last 6 months.

I have had cosmetic treatments on my face within certain time limits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible patients will receive 1-2 face and/or neck and/or submental treatments using the SofWave system with the Lift or/and Precise applicators

2-12 weeks

1-2 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

Trial Overview The study tests the Sofwave treatment's effectiveness on lifting loose facial skin and reducing wrinkles. It's an open-label, single-arm study where all participants receive the same treatment with outcomes evaluated by masked assessors.

How Is the Trial Designed?

Group I: lax tissue 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

High-Intensity Focused Ultrasound (HIFU) demonstrated significant clinical efficacy in improving skin laxity and reducing wrinkles, with an average improvement of 58% as assessed by dermatologists and 60% by patients three months post-treatment.

The study, involving 22 women aged 35-62, confirmed that HIFU is a safe treatment option, as all participants completed the study without reported adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of efficacy of esthetic High-Intensity Focused Ultrasound system on Iranian skin for reducing the laxity and wrinkles of aging. Saket, P., Shobeihi, S., Mehrdadi, S.[2018]

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]

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 study involving 30 healthy women with mild to moderate skin laxity above the knees, micro-focused ultrasound with visualization (MFU-V) demonstrated significant efficacy, with 86% of participants showing improvement in skin lifting and tightening after 90 and 180 days.

The treatment was found to be safe, with no adverse events or skin injuries reported, indicating that MFU-V is a promising noninvasive option for improving skin appearance in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). Gold, MH., Sensing, W., Biron, J.[2015]

Transcutaneous microfocused ultrasound with visualization is a safe and effective noninvasive treatment for improving skin laxity and ptosis in the face and neck, as demonstrated in a study involving 50 participants with a mean age of 52.8 years.

Significant improvements were observed in wrinkles, skin texture, and patient satisfaction after a single treatment session, with no major side effects reported, indicating good tolerability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Study on Clinical Efficacy and Safety of a Single Session of Microfocused Ultrasound With Visualization for Collagen Regeneration. Araco, A.[2021]

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]

Citations

1. sofwave.com sofwave.com/providers/body

Sofwave Body Treatments for Non-Invasive Lifting and ... A revolutionary treatment that is the only non-invasive, FDA-cleared, energy-based treatment to improve upper arm laxity without surgery or scarring.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38031530/

Efficacy and safety of high-intensity, high-frequency, non- ... Background: Ultrasound energy has been used for dermal rejuvenation to treat fine lines, wrinkles and to lift lax skin.

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11845918/

High‐Intensity, Parallel Ultrasound Tightening of Facial Skin HIPS tightening is an innovative treatment method for skin laxity, generating thermal effects at depths of 1–2 mm while preserving the overlying epidermis.

5. 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 to improve the appearance of skin laxity on the upper arms. The Pure Impact module is indicated to be used for:.

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/pdf23/K233104.pdf

December 22, 2023 Sofwave Medical Ltd. Janice Hogan ... The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the ...

8. sofwave.com sofwave.com/blog/are-ultrasound-waves-harmful-to-your-skin

Are Ultrasound Waves Harmful to Your Skin? The key takeaway we hope you will walk away with is that ultrasound technology is a safe and effective procedure for treating facial skin.