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SofWave for Lower Face and Neck Rejuvenation

This study is looking at how well the SofWave system works to improve wrinkles, jawline shape, and loose skin in the lower face and neck. SofWave uses high-intensity ultrasound energy delivered to the skin. We are looking for healthy non-smokers, aged 40-55, with mild to moderate loose skin in these areas who want to improve their appearance. The main goal is to see how effective the treatment is for rejuvenation of the lower face and upper neck, measured 12 weeks after your last treatment. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the SofWave treatment. It plans to enroll 30 participants.
What's involved
You would receive 1 or 2 SofWave treatments, 4-6 weeks apart. You would then have 3 follow-up visits: at 4 weeks, 12 weeks, and 24 weeks after your last treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 weeks after their last treatment.

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NCT07723664

Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation

Not Yet Recruiting
NAAges 40–55InterventionalTreatment
Sofwave Medical LTD
~30 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:SofWave

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
Measured over 12 weeks post treatment follow-up visit
+1 more outcome measured

Conditions

Facial Wrinkles
Jawline Contour
Skin Laxity

Explore related trials

Cutis LaxaJawline ContourWrinkled face

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Shlomit Mann, MSc
[email protected]
+972-4-7800268
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
Injectable filler treatments in the past 6 months
Injectable neuromodulator treatment in the past 4 months 18. Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months. 19. Taking anti-platelet or anti-coagulant within the past 2 weeks. 20. Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks. 21. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

What this trial measures

  • Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation12 weeks post treatment follow-up visit

    Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)

  • Lower face and upper neck rejuvenation12 weeks post treatment follow-up visit

    Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.