Can sound waves tighten loose skin after weight loss?

NCT ID NCT07685834

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tests whether a device called SofWave, which uses ultrasound energy, can improve loose skin on the face and neck. It includes healthy women aged 30-50 who are starting tirzepatide for weight loss. Half receive SofWave treatments, and the other half serve as a control group. The goal is to see if the treatment reduces skin laxity compared to no treatment.

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
What this could lead to
If it works, this could offer a non-surgical way to tighten loose skin after weight loss.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply to everyone. The treatment may not improve skin laxity as hoped.
Why investors are watching

Sofwave Medical is testing whether its ultrasound skin-tightening device can reduce facial and neck laxity in adults who start taking tirzepatide for weight loss. The trial is small, with 30 participants, and it is a pilot study, so the readout will show early signals rather than proof. For a micro-cap company, this result matters because it could open a new use case for its device in the growing weight-loss market.

If it works: A positive result could position Sofwave's device as a complementary treatment for skin laxity after weight loss, which may attract interest from clinics and patients. That could broaden the company's revenue base beyond its current aesthetic uses.

If it fails: The trial could fail to show meaningful improvement, or the small size may produce unclear results. Pilot studies often do not lead to commercial products, and a weak readout could slow adoption of the device for this purpose.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

30 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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 subjects between the ages 30-50. 2. Eligible to start on Tirzepatide treatment for weight loss. 3. Non-diabetic. 4. BMI\>30. 5. Non-Smoker. 6. Desire to lift facial and neck skin laxity, and/or desire to lift the eyebrow area and/or improve facial wrinkles. 7. Able and willing to comply with all visits, treatments and evaluation schedules and requirements. 8. Able to understand and provide written Informed Consent. 9. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment. 10. Subject agrees not to undergo any other facial cosmetic treatment during the study course. Exclusion Criteria: 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. BMI \< 30 3. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years. 4. Melanoma, active non-cutaneous malignancy, or history of non-cutaneous malignancy in the past 5 years. 5. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck). 6. Previous chemotherapy treatments. 7. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or the healing process). 8. History of chronic drug or alcohol abuse. 9. History of epileptic seizures. 10. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. 11. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgens. 12. History of significant lymphatic drainage problems within the facial areas. 13. History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen deposition disorders, vascular disease, scleroderma, or vasculitic disorders. 14. Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.) 15. Known allergy to Lidocaine, Tetracaine, Xylocaine, Epinephrine or antibiotics. 16. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks. 17. Severe solar elastosis in the intended to treat area. 18. Tattoo or former tattoo at or near treatment area. 19. Tendency for melasma. 20. Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising. 21. Surgical or traumatic scar in the intended to treat area. 22. Presence of a metal stent or implant in the facial area (e.g. braces; dental implants are not excluded). 23. 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. 24. Presence of any active systemic or local infections. 25. Severe or cystic facial acne, and/or Accutane use during past 6 months. 26. Undergo any kind of facial surgery over the last 12 months. 27. Inability to understand the protocol or to provide a signed informed consent. 28. 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.

cutis laxa Facies Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dr.Jean Carruthers Cosmetic Surgery

    Vancouver, Canada

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