Not Yet RecruitingNot Applicable

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

United States30 participantsStarted 2026-07-20

Plain-language summary

Non-randomized single-arm prospective clinical study.

Who can participate

Age range

40 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy female and male subjects between the ages 40-55.
. Non-Smoker.
. Fitzpatrick skin type I-VI.
. Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
. Presence of mild to moderate laxity in the lower face and submental area.
. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
. Able to understand and provide written Informed Consent.
. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

Exclusion criteria

. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
. Presence of any active systemic or local infections.
. Open wounds or lesions within the intended to treat area.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation

Timeframe: 12 weeks post treatment follow-up visit

Lower face and upper neck rejuvenation

Timeframe: 12 weeks post treatment follow-up visit

Trial details

NCT IDNCT07723664

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-15

Contact for this trial

Shlomit Mann, MSc

+972-4-7800268 Shlomit@sofwave.com

View on ClinicalTrials.gov More Facial Wrinkles trials