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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Pure Impact and Sofwave (a focused ultrasound stimulator system for aesthetic use), to evaluate their effectiveness on sagging skin and muscles in the upper arms. The goal is to improve skin tightness and muscle tone. Ideal candidates for this trial have visibly sagging skin on their upper arms and wish to enhance their skin's appearance and muscle strength. Participants should not have undergone recent treatments or surgeries on their upper arms and must be willing to maintain their current weight and lifestyle during the study. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for improving skin and muscle tone.

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 prior data suggests that the Sofwave and Pure Impact treatments are safe for sagging skin?

Research has shown that both Sofwave and Pure Impact are safe treatments. Sofwave uses ultrasound technology, which is non-invasive and FDA-approved. It helps tighten loose skin and is safe for all skin types. No major long-term problems have been reported with this technology.

Pure Impact uses electrical muscle stimulation (EMS) and is also FDA-approved, indicating its safety for certain uses. Pure Impact helps strengthen and tone muscles. Like Sofwave, it has a strong safety record, with studies reporting no serious side effects.

Both treatments are generally well-tolerated by patients and aim to improve the appearance of skin and muscles without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for sagging skin, which often rely on surgical procedures or injectable fillers, Sofwave and Pure Impact offer a non-invasive alternative. Sofwave uses advanced ultrasound technology to stimulate collagen production deep within the skin, promoting natural lifting and tightening without downtime. Pure Impact complements this by enhancing the skin’s firmness and elasticity through innovative topical formulations. Researchers are excited because these treatments provide a safer, needle-free option with potentially quicker recovery times, making them accessible to a broader range of individuals seeking to rejuvenate their skin.

What evidence suggests that Sofwave and Pure Impact are effective for sagging skin?

Research has shown that Sofwave effectively improves loose skin, lifting, and toning. It uses ultrasound energy, proven to help with fine lines and wrinkles. Before and after photos demonstrate clear improvements in skin tightness. In this trial, participants will receive a combination of Sofwave and Pure Impact, offering a non-invasive way to enhance muscle tone. This combination has improved the appearance of sagging skin. Together, these treatments provide a low-downtime option for addressing skin sagging. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sofwave.com sofwave.com/blog/improving-aesthetic-results-for-glp-1-patients-with-sofwave-and-pure-impact

The Evolution of Non-Invasive Skin Lifting While surgery offers more dramatic results, Sofwave™ and Pure Impact™ provide non-invasive, low-downtime alternatives ideal for patients with ...

2. withpower.com withpower.com/trial/sofwave-pure-impact-for-sagging-skin-71155

Sofwave + Pure Impact for Sagging Skin · Info for Participants The study validated the safety and effectiveness of a noninvasive focused ultrasound technology for body contouring, showing that it can cause fat cell lysis ...

3. selflondon.com selflondon.com/sofwave-and-pure-impact-a-structural-approach-to-modern-ageing/

Sofwave and Pure Impact These agents, while effective for weight management, can accelerate both facial fat loss and muscle depletion, creating a presentation that is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12475914/

Evaluation of Improvement in Skin Laxity and Oiliness After ... Significant improvements in jawline sagging and nasolabial folds were observed in 2D/3D images. Quantitative analysis confirmed RF‐induced skin ...

5. sofwave.com sofwave.com/news/sofwave-receives-fda-clearance-for-pure-impacttm-in-strengthening-and-firming-of-arms-in-the-u-s

Sofwave Receives FDA Clearance for Pure ImpactTM in ... Not only can the Sofwave system be used to improve dermal laxity of the arms, but the increased muscle tone achieved with Pure Impact™ module ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07094971

Pure Impact Treatment to Strengthen and Tone Abdomen ... Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4631236/

Radiofrequency for the treatment of skin laxity: mith or truth The nonablative radiofrequency is a procedure commonly used for the treatment of skin laxity from an increase in tissue temperature.

8. sofwave.com sofwave.com/glp1-solutions-sofwave-pure-impact

Reclaim Your Confidence Post-GLP-1 Weight Loss - LP FDA-Cleared. 7 Clearances · Minimal Downtime. No Aftercare · Boosts Collagen. For Natural Appearance · Safe For All Skin Tones. Safe & Effective.