Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

Study Overview

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

Detailed Description

This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat 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 (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. Treatment may be administered after the enrollment and screening at the first visit or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • SLSS, a Division of Schweiger Dermatology Group Research Office
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
    • Nashville, Tennessee, United States, 37203
      • The Practice of Brian S. Biesman, MD
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • McDaniel Institute of Aging Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

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.
Experimental: "off the face" areas; "off the face" areas: abdomen, or arms or thighs or Décolleté.	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
Improvements in lifting of lax tissue	as assessed by independent masked evaluators of pre and post treatment images.	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): January 10, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: March 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: Sofwave05

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