Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

NCT04829227 | Completed Phase 3 FDA Device

• 1 other identifier: Sofwave05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Skin Laxity

Keywords

Laxity Brow Lifting Skin Saggy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

face and/or neck and/or submental zones

EXPERIMENTAL

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

"off the face" areas

EXPERIMENTAL

"off the face" areas: abdomen, or arms or thighs or Décolleté.

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.

"off the face" areas; face and/or neck and/or submental zones

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male subjects between the ages 35-80.
• Non-Smoker.
• Fitzpatrick skin type I-VI.
• Desire to lift lax skin in the neck and submental and/or to lift the brows.
• Able and willing to comply with all visit, treatment 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.

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.
• Presence of active local skin disease that may alter wound healing.
• Severe solar elastosis.
• History of smoking in past 10 years.
• History of chronic drug or alcohol abuse.
• Excessive subcutaneous fat on the cheeks.
• Significant scarring in the area to be treated.
• Severe or cystic facial acne, acutance uses during past 6 months.
• Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
• Inability to understand the protocol or to give informed consent.
• 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.
• Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
• As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (4)

SLSS, a Division of Schweiger Dermatology Group Research Office

Hackensack, New Jersey, 07601, United States

Location

The Practice of Brian S. Biesman, MD

Nashville, Tennessee, 37203, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

McDaniel Institute of Aging Research

Virginia Beach, Virginia, 23462, 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

Study Officials

• Ruthie Amir, MD

  Sofwave

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: January 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2021-03

Locations

US (4)