Sofwave + Pure Impact for Sagging Skin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sofwave Medical LTD

Must not be taking: Immunosuppressants, Blood thinners

Disqualifiers: Pregnancy, Skin disorders, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4-6 weeks

70 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking any medication that might increase your risk of bruising, the investigator may advise against it.

What data supports the effectiveness of the treatment Sofwave + Pure Impact for sagging skin?

Research shows that ultrasound energy, like that used in Sofwave, can effectively lift and tighten skin by remodeling collagen, which is a protein that helps keep skin firm. This type of treatment has been approved by the FDA for improving facial features such as eyebrows and neck, and it is known for high patient satisfaction and minimal recovery time. ^{1 2 3 4 5}

Is Sofwave + Pure Impact safe for treating sagging skin?

Sofwave, which uses ultrasound technology, is generally considered safe for skin tightening, with high patient satisfaction and minimal recovery time. It has been approved by the FDA for facial rejuvenation, and studies show it has an excellent safety profile. ^{1 6 7 8 9}

How is the Sofwave + Pure Impact treatment for sagging skin different from other treatments?

The Sofwave + Pure Impact treatment is unique because it uses ultrasound technology to deliver energy to the skin, stimulating collagen and elastin production for tightening and rejuvenation without surgery. This approach offers minimal recovery time and high patient satisfaction compared to more invasive procedures. ^{1 4 10 11 12}

What is the purpose of this trial?

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study.

Eligibility Criteria

This trial is for men and women aged 25-70 with visible sagging skin on the upper arms who want to improve it. Participants must be able to follow the study plan, not have other arm treatments for 3 months after joining, and keep their weight stable. They can't join if they're pregnant or breastfeeding, allergic to certain anesthetics or hydrogel, very overweight, heavy smokers, or have a history of certain diseases.

Inclusion Criteria

Able to understand and provide written Informed Consent

Able and willing to comply with all visits, treatments, and evaluation schedules and requirements

Willing to have research photos taken of treatment areas

Exclusion Criteria

Known allergy to lidocaine or epinephrine

I have had cancer or still have it within the last 5 years.

Pregnant, planning to become pregnant, given birth less than 3 months ago, or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined treatment on both upper arms, including 1 or 2 SofWave treatments and 4 Pure Impact treatments

4-6 weeks

Multiple visits for SofWave and Pure Impact treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person) at 4±1 weeks and 12±2 weeks post last treatment

Treatment Details

Interventions

• Pure Impact
• Sofwave

Trial Overview The trial tests Sofwave and Pure Impact treatments combined to see how well they strengthen muscles and tighten loose skin on the upper arms. It's an open-label study where everyone knows what treatment they get; it's also non-randomized so there’s no chance involved in who gets treated.

Participant Groups

Group I: Lax Tissue and Muscles Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sofwave Medical LTD

Lead Sponsor

Trials

11

Recruited

640+

Findings from Research

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]

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]

Transcutaneous intense focused ultrasound is a safe and effective noninvasive treatment for skin tightening in nonfacial areas, such as the upper arms, knees, and thighs, with significant improvements observed at 3 and 6 months post-treatment.

Dual-plane treatment using two different ultrasound frequencies resulted in slightly better clinical improvement scores compared to single-plane treatment, indicating that treatment technique may enhance efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound. Alster, TS., Tanzi, EL.[2012]

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]

References

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

Ultrasound Therapy for the Skin. [2023]

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

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

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

The efficacy and safety of intense focused ultrasound in the treatment of enlarged facial pores in Asian skin. [2022]

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

Selective transcutaneous delivery of energy to porcine soft tissues using Intense Ultrasound (IUS). [2022]

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

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

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

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

7. England pubmed.ncbi.nlm.nih.gov

Intense focused ultrasound for neck and lower face skin tightening a prospective study. [2021]

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

Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound. [2012]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

[High intensity focussed ultrasound for skin tightening]. [2023]

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

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

12. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. [2023]