Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Sofwave Medical LTD
Summary
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Description
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…
Eligibility
- Age range
- 35–80 years
- Sex
- All
- Healthy volunteers
- Yes
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 facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance. 5. Able and willing to comply with all visits, treatments 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. 8. Subject agrees not to undergo any other fa…
Interventions
- DeviceSofwave
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Locations (2)
- Costal Skin & Eye InstituteLa Mesa, California
- Skin Wellness Dermatology AssociatesDurham, North Carolina