Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight Loss

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.

• SUPERB (Device): 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.

Primary outcomes

• Improvement in the appearance of lax skin [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).

Secondary outcomes

• Histology [20 weeks post last treatment]: 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.

Sex: Female, ages: 30 Years to 50 Years, accepts healthy volunteers

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.