NCT06333067

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

Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 carried out at each visit at the clinic.

Conditions

• Lax Skin

Interventions

Type	Name	Description
DEVICE	Sofwave	The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.

Timeline

• Start date: 2023-10-11
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2024-03-27
• Last updated: 2025-05-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study