Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Recruiting now · Not applicable

Conditions studied: Lax Skin

In brief

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

Key facts

Study ID

NCT06333067

Run by

Sofwave Medical LTD

People needed

100

Starts

2023-10-11

Expected to finish

2025-11-01

Last updated by the study team

2025-05-13

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 facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
• 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.

You may not qualify if…

• 1. 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.
• Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) 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.
• Severe or cystic facial acne, and/or Accutane use 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 provide a signed informed consent.
• History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 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

• Costal Skin & Eye Institute — La Mesa, California, United States (enrolling)
• Skin Wellness Dermatology Associates — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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