Sound waves and muscle zaps aim to tighten sagging skin without surgery
NCT ID NCT07685821
First seen Jul 06, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This study tests whether a single treatment with the SofWave device—which combines high-intensity ultrasound and electrical muscle stimulation—can tighten loose skin and reduce wrinkles by stimulating fibroblasts, the cells that produce collagen. Ten healthy adults aged 35 to 60 with mild to moderate skin laxity will receive one treatment and provide skin biopsies to measure tissue changes. The goal is to see if the treatment triggers natural remodeling of the skin without the need for surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SofWave ultrasound device with Pure Impact EMS module
- What this could lead to
- If successful, this could offer a non-surgical option for tightening loose skin and reducing facial wrinkles.
- What could go wrong
- This is a very small early study with only 10 participants, so results may not apply to everyone. The treatment involves skin biopsies and may cause temporary redness or swelling.
Why investors are watching
Sofwave Medical is testing whether a single treatment with its SofWave device can remodel tissue by stimulating fibroblasts, the cells that produce collagen. The trial enrolls only 10 participants and is open-label, meaning everyone knows they received the treatment. For a micro-cap company, this small study is a key early signal on whether the device works as claimed, which could shape investor confidence in its technology.
If it works: A positive result could support Sofwave's marketing claims and help the company attract more customers or partners for its device. It might also strengthen the case for larger studies that could broaden the device's approved uses.
If it fails: A negative or unclear result could raise doubts about the device's effectiveness and hurt the company's reputation. Trials often fail, and with only 10 participants, the study may not produce reliable or meaningful data either way.
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
-
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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
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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35 to 60 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 35-60 2. Non-Smoker. 3. Fitzpatrick skin type I-VI. 4. Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance. 5. Willing to give biopsies. 6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements (including providing biopsies). 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. 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. Presence of active local skin disease that may alter wound healing. 4. Severe solar elastosis. 5. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years. 6. History of chronic drug or alcohol abuse. 7. Excessive subcutaneous fat on the cheeks. 8. Significant scarring in the area to be treated. 9. Severe or cystic facial acne, and/or Accutane use during past 6 months. 10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded). 11. Inability to understand the protocol or to provide a signed informed consent. 12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months. 13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks. 14. 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.
Contacts and locations
Locations
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Dermatology Cosmetic Laser Associates of La Jolla, Inc
San Diego, California, 92121, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.