High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two treatments, Sofwave® and Ultherapy®, for tightening loose skin on the upper inner arms. Sofwave® uses sound waves, while Ultherapy® uses ultrasound energy. The study aims to see which method is more effective for individuals with loose skin in this area.

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.

What data supports the effectiveness of the treatment Sofwave, Sofwave System, Focused Ultrasound Stimulator System for Aesthetic Use, Ultherapy?

Research shows that microfocused ultrasound with visualization (MFU-V), like Ultherapy, is effective for non-invasive skin lifting and tightening, particularly on the face and neck. It works by stimulating the production of collagen, which helps rejuvenate and tighten the skin. ^{1 2 3 4 5}

Is the ultrasound treatment safe for humans?

The ultrasound treatment, including systems like Sofwave and Ultherapy, is generally safe for humans. Studies show that side effects are usually mild and temporary, such as tenderness, redness, and slight swelling. Rare side effects can occur, often due to improper use, but when used correctly, the treatment is considered safe. ^{6 7 8 9 10}

How does the Sofwave and Ultherapy treatment differ from other treatments for skin conditions?

Sofwave and Ultherapy use high-intensity focused ultrasound (HIFU) to target specific layers of the skin with precision, allowing for treatment without damaging surrounding tissues. This makes them unique compared to other treatments that may not offer the same level of precision and safety. ^{3 11 12 13 14}

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Sofwave
• Ultherapy

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Single Treatment, Single Depth Superficial Microfocused Ultrasound with Visualization for Rhytid Improvement. [2022]

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

Evaluation of Micro-Focused Ultrasound for Lifting and Tightening Neck Laxity. [2019]

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

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

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

Noninvasive skin tightening: focus on new ultrasound techniques. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Practical Guidance for Optimizing Patient Comfort During Microfocused Ultrasound with Visualization and Improving Patient Satisfaction. [2020]

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

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

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

Ultrasound Therapy for the Skin. [2023]

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

Medical devices; general and plastic surgery devices; classification of the focused ultrasound stimulator system for aesthetic use. Final rule. [2011]

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

In Vivo Non-Thermal, Selective Cancer Treatment With High-Frequency Medium-Intensity Focused Ultrasound. [2022]

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

"HIFU Beam:" A Simulator for Predicting Axially Symmetric Nonlinear Acoustic Fields Generated by Focused Transducers in a Layered Medium. [2022]

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

Bypassing absorbing objects in focused ultrasound using computer generated holographic technique. [2017]

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

Spatio-Spectral Ultrasound Characterization of Reflection and Transmission Through Bone With Temperature Dependence. [2022]