Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Completed · Phase 3

Conditions studied: Skin Laxity

In brief

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

Key facts

Study ID

NCT04829227

Run by

Sofwave Medical LTD

People needed

45

Starts

2020-01-10

Expected to finish

2021-12-31

Last updated by the study team

2022-10-26

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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