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

Trial Summary

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 data supports the effectiveness of the treatment Sofwave for loose skin?

Research shows that ultrasound energy, like that used in Sofwave, can effectively lift and tighten skin by remodeling collagen. Sofwave and similar systems have been approved for lifting eyebrows, neck, and reducing facial wrinkles, with high patient satisfaction and minimal recovery time. ^{1 2 3 4 5}

How is the Sofwave treatment different from other treatments for loose skin?

Sofwave is unique because it uses focused ultrasound energy to target specific layers of the skin, stimulating collagen production without affecting surrounding tissues. This non-invasive approach offers a safe and effective option for skin tightening with minimal recovery time compared to surgical methods. ^{1 2 3 5 6}

What is the purpose of this trial?

Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). [2015]

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

Ultrasound Therapy for the Skin. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2018]