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Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators. 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 visit at 3 months ± 2 weeks post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
Age
35 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Costal Skin & Eye Institute
La Mesa, California, United States
Skin Wellness Dermatology Associates
Durham, North Carolina, United States
Start Date
October 11, 2023
Primary Completion Date
October 1, 2025
Completion Date
November 1, 2025
Last Updated
May 13, 2025
100
ESTIMATED participants
Sofwave
DEVICE
Lead Sponsor
Sofwave Medical LTD
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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