NCT04829227

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. 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 visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.

Conditions

• Skin Laxity

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: 2020-01-10
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-04-02
• Last updated: 2022-10-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study