Sound waves to smooth wrinkles? a trial tests ultrasound for a non-surgical facelift
NCT ID NCT07723664
First seen Jul 23, 2026 · Last updated Jul 28, 2026 · Updated 3 times
Summary
This trial tests whether a device called SofWave, which delivers high-intensity ultrasound energy under the skin, can lift and tighten the lower face and upper neck. About 30 healthy adults aged 40 to 55 with mild to moderate skin laxity will receive one treatment. Doctors will rate the improvement in skin appearance 12 weeks later using a standard scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- high-intensity focused ultrasound energy delivered by the SofWave device
- What this could lead to
- If it works, this could offer a non-surgical option for tightening loose skin and reducing wrinkles on the lower face and neck.
- What could go wrong
- This is a small, early trial with no comparison group. Results may not apply to everyone, and the effects may be modest or temporary.
Why investors are watching
Sofwave Medical, a micro-cap company, is running a small 30-person study of its software-guided energy device for lower face and neck rejuvenation. The readout matters because this is a single-arm trial with no control group, so any positive result would show the device works in a real-world setting, which could support its commercial claims. For a company this size, one clinical result can shift its entire outlook.
If it works: A positive result could strengthen the company's marketing claims and help it win more customers among clinics and doctors. It might also support regulatory or reimbursement discussions, giving the company a clearer path to grow sales.
If it fails: The trial could fail to show meaningful improvement, or the company could face delays in reporting results. Trials often fail, and with only 30 participants and no comparison group, the findings may be too weak to convince doctors or investors.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy female and male subjects between the ages 40-55. 2. Non-Smoker. 3. Fitzpatrick skin type I-VI. 4. Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance. 5. Presence of mild to moderate laxity in the lower face and submental area. 6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements. 7. Able to understand and provide written Informed Consent. 8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment. 9. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment. 10. Stable weight over the last 12 weeks and throughout the duration of the study. 11. Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+. 12. Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography. \- Exclusion Criteria: 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. Presence of any active systemic or local infections. 3. Open wounds or lesions within the intended to treat area. 4. Tattoo or former tattoo at or near treatment area. 5. Presence of active local skin disease that may alter wound healing. 6. Uncontrolled diabetes mellitus. 7. Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck). 8. Severe solar elastosis. 9. History of smoking in the past 10 years. 10. History of chronic drug or alcohol abuse. 11. Excessive subcutaneous fat on the cheeks. 12. Significant scarring in the area to be treated or history of keloids. 13. Severe or cystic facial acne, and/or Accutane use during the past 6 months. 14. Pacemakers and electronic device implants in the treated area. 15. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded). 16. Inability to understand the protocol or to provide a signed informed consent. 17. History of cosmetic treatments in the area to be treated including: * 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. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dermatology & Laser Surgery Center
Houston, Texas, 77004, United States
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