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

NCT07685834 | Active Not Recruiting

• 1 other identifier: SofWave30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, randomized double-arm prospective, single-center, self-controlled clinical study.

Conditions

Lax Skin

Keywords

Face; Lax Skin; Neck; Tirzepatide; GLP-1; Weight loss

Outcome Measures

Primary Outcomes (1)

• 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).

  20 WEEKS POST LAST TREATMENT

Secondary Outcomes (1)

• Histology

  20 weeks post last treatment

Study Arms (2)

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.

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.

Interventions

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.

Treatment group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (1)

Dr.Jean Carruthers Cosmetic Surgery

Vancouver, Canada

Location

MeSH Terms

Conditions

Cutis Laxa; Facies; Weight Loss

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

CA (1)