Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation

NCT07723664 | Not Yet Recruiting FDA Device

• 1 other identifier: SofWave31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Non-randomized single-arm prospective clinical study.

Conditions

Facial Wrinkles; Jawline Contour; Skin Laxity

Keywords

lower face; upper neck; submental; facial wrinkles; jawline contour; skin laxity

Outcome Measures

Primary Outcomes (2)

• Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation

  Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)

  12 weeks post treatment follow-up visit

• Lower face and upper neck rejuvenation

  Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.

  12 weeks post treatment follow-up visit

Study Arms (1)

Experimental: lax tissue

EXPERIMENTAL

Device: SofWave

Interventions

SofWave 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

Experimental: lax tissue

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female and male subjects between the ages 40-55.
• Non-Smoker.
• Fitzpatrick skin type I-VI.
• Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
• Presence of mild to moderate laxity in the lower face and submental area.
• 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 for a period of 3 months following last SofWave treatment.
• Stable weight over the last 12 weeks and throughout the duration of the study.
• Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
• Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• Presence of any active systemic or local infections.
• Open wounds or lesions within the intended to treat area.
• Tattoo or former tattoo at or near treatment area.
• Presence of active local skin disease that may alter wound healing.
• Uncontrolled diabetes mellitus.
• Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
• Severe solar elastosis.
• History of smoking in the past 10 years.
• History of chronic drug or alcohol abuse.
• Excessive subcutaneous fat on the cheeks.
• Significant scarring in the area to be treated or history of keloids.
• Severe or cystic facial acne, and/or Accutane use during the past 6 months.
• Pacemakers and electronic device implants in the treated area.
• Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (1)

Dermatology & Laser Surgery Center

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Cutis Laxa

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

Central Study Contacts

Shlomit Mann, MSc

CONTACT

+972-4-7800268; Shlomit@sofwave.com

Ruthie Amir, MD

CONTACT

+972-4-300-3164; ruthie@sofwave.com

Study Design

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

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

US (1)