SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Safety and Efficacy of Sofacia Treatment to Improve Facial Lines and Wrinkles, to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Study Overview

• Status: Completed
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Sofwave

Detailed Description

Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and submental zones including 1. The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin.

All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruthie Amir, MD; Phone Number: +972-4-6432994; Email: ruthie@sofwave.com
• Study Contact Backup: Name: Shlomit Mann, MSc; Phone Number: +972-4-6432994; Email: shlomit@sofwave.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy female and male subjects between the ages 35-80.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to lift lax skin in the neck and submental and/or to lift the brows.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent
7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Severe solar elastosis.
5. History of smoking in past 10 years.
6. History of chronic drug or alcohol abuse.
7. Excessive subcutaneous fat on the cheeks.
8. Significant scarring in the area to be treated.
9. Severe or cystic facial acne, acutance uses during past 6 months.
10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
11. Inability to understand the protocol or to give informed consent.
12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 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.
13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: face and/or neck and/or submental zones; the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck	Device: Sofwave; The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lift of lax tissue	As assessed by independent masked evaluators. Quantitative image analysis to objectively measure change in lift of the eyebrow and submental and neck lax tissue would be conducted by comparing baseline images to those taken at each visit post FU1 (Pre Tx.2, FU2)	3 and 6 months post last treatment

Collaborators and Investigators

• Sponsor: Sofwave Medical LTD
• Investigators: Study Director: Ruthie Amir, MD, Sofwave

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Laxity Brow Lifting Skin Saggy
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: UCI IRB HS# 2019-5520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No