Lax SkinNCT07685834
Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss
A study testing SUPERB in people with Lax Skin, run by Sofwave Medical LTD at 1 site in Canada.
Trial summary
Open-label, randomized double-arm prospective, single-center, self-controlled clinical study. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lax Skin
- What is being tested?
- SUPERB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects between the ages 30-50.
- Eligible to start on Tirzepatide treatment for weight loss.
- Non-diabetic.
- BMI>30.
- Non-Smoker.
- Desire to lift facial and neck skin laxity, and/or desire to lift the eyebrow area and/or improve facial wrinkles.
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- 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.
- Subject agrees not to undergo any other facial cosmetic treatment during the study course.
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- BMI < 30
- Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- Melanoma, active non-cutaneous malignancy, or history of non-cutaneous malignancy in the past 5 years.
- History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
- Previous chemotherapy treatments.
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- 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).
- History of chronic drug or alcohol abuse.
- History of epileptic seizures.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgens.
- History of significant lymphatic drainage problems within the facial areas.
- History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen deposition disorders, vascular disease, scleroderma, or vasculitic disorders.
- Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- Known allergy to Lidocaine, Tetracaine, Xylocaine, Epinephrine or antibiotics.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
- Severe solar elastosis in the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Tendency for melasma.
- Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
- Surgical or traumatic scar in the intended to treat area.
- Presence of a metal stent or implant in the facial area (e.g. braces; dental implants are not excluded).
- 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.
- Presence of any active systemic or local infections.
- Severe or cystic facial acne, and/or Accutane use during past 6 months.
- Undergo any kind of facial surgery over the last 12 months.
- Inability to understand the protocol or to provide a signed informed consent.
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Observational Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss
Open-label, randomized double-arm prospective, single-center, self-controlled clinical study.
Read the detailed description
Eligible subjects are patients who are interested in starting treatment with Tirzepatide injections.
Subjects will be divided into two groups. The test group will include at least 10 subjects who will be treated to characterize changes in facial and neck skin laxity as well as facial wrinkles in relation to SofWave treatment, in a population of subjects beginning Tirzepatide for weight loss.
The control group will also include at least 10 subjects, who will not be treated.
In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects in each group.
All Subjects will receive their first Tirzepatide injection within 48 hours after baseline assessment (± biopsy).
Treatment Group:
Subjects will receive two SofWave treatments, 4 weeks apart, applied to the full face and neck.
Three subjects will undergo biopsies at baseline (2 weeks before first treatment) and at Week 26 (20 weeks after the second treatment).
Biopsy subjects will attend additional visits, including telehealth follow-ups to monitor healing.
Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Final follow-up occurs approximately 24-26 weeks after the first treatment.
Control Group:
Subjects will not receive SofWave during the study period. Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Three subjects will undergo biopsies at Week 0 and Week 24, with additional telehealth follow-ups.
- Conditions
- Lax Skin
- Being tested
- SUPERB
- Keywords
- Face, Lax Skin, Neck, Tirzepatide, GLP-1, Weight loss
- Medical subject headings
- Cutis Laxa, Facies, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPERBDevice
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | (at least 10 subjects) will undergo 2 SofWave treatments (4 weeks apart) on the face and submental areas. In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects of the treatment group. Receives: Device: SUPERB |
| Control group | No intervention | The control subjects (at least 10 subjects) will have 3 in-person visits. 3 of these subjects will also have biopsies taken during their first visit and at second follow-up (FU2) at week 24. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the appearance of lax skin
The efficacy endpoint criteria for success is defined as the rate of 'improved' or 'no change' at the Treatment group compared to Control group at 20 weeks post last SofWave treatment for Treatment group and following FU1 for Control group (FU2).
Measured: 20 WEEKS POST LAST TREATMENT
Secondary outcomes (1)
Histology
The histological effects will be determined via H\&E (Haematoxylin and Eosin) staining and special staining such as Alcian Blue, Masson trichrome and/or Verhoeff Van Gieson staining.
Measured: 20 weeks post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start27 Feb 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lax SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685834
- Sponsor's protocol ID
- SofWave30
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss
- ClinicalTrials.gov ID
- NCT07685834
- Acronym / sponsor ID
- SofWave30
- Conditions
- Lax Skin
- Keywords
- Face, Lax Skin, Neck, Tirzepatide, GLP-1, Weight loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, randomized double-arm prospective, single-center, self-controlled clinical study.
Detailed description
Eligible subjects are patients who are interested in starting treatment with Tirzepatide injections.
Subjects will be divided into two groups. The test group will include at least 10 subjects who will be treated to characterize changes in facial and neck skin laxity as well as facial wrinkles in relation to SofWave treatment, in a population of subjects beginning Tirzepatide for weight loss.
The control group will also include at least 10 subjects, who will not be treated.
In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects in each group.
All Subjects will receive their first Tirzepatide injection within 48 hours after baseline assessment (± biopsy).
Treatment Group:
Subjects will receive two SofWave treatments, 4 weeks apart, applied to the full face and neck.
Three subjects will undergo biopsies at baseline (2 weeks before first treatment) and at Week 26 (20 weeks after the second treatment).
Biopsy subjects will attend additional visits, including telehealth follow-ups to monitor healing.
Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Final follow-up occurs approximately 24-26 weeks after the first treatment.
Control Group:
Subjects will not receive SofWave during the study period. Non-biopsy subjects will attend 3 in-person visits (Baseline, Week 4, Week 24). Three subjects will undergo biopsies at Week 0 and Week 24, with additional telehealth follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: SUPERB(at least 10 subjects) will undergo 2 SofWave treatments (4 weeks apart) on the face and submental areas. In addition, small superficial punch biopsies in the submental area will be taken from 3 subjects of the treatment group. |
| Control group | No intervention | –The control subjects (at least 10 subjects) will have 3 in-person visits. 3 of these subjects will also have biopsies taken during their first visit and at second follow-up (FU2) at week 24. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy female subjects between the ages 30-50.
- Eligible to start on Tirzepatide treatment for weight loss.
- Non-diabetic.
- BMI>30.
- Non-Smoker.
Key exclusion criteria (28 listed)
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- BMI < 30
- Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
- Melanoma, active non-cutaneous malignancy, or history of non-cutaneous malignancy in the past 5 years.
- History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPERBThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. | Device | Treatment group |
Primary outcome
Improvement in the appearance of lax skin
Time frame: 20 WEEKS POST LAST TREATMENT
The efficacy endpoint criteria for success is defined as the rate of 'improved' or 'no change' at the Treatment group compared to Control group at 20 weeks post last SofWave treatment for Treatment group and following FU1 for Control group (FU2).
1 secondary outcome
Histology
Time frame: 20 weeks post last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPERB in people with Lax Skin, run by Sofwave Medical LTD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the appearance of lax skin (time frame: 20 WEEKS POST LAST TREATMENT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.