Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Skin Laxity Clinical Trial

Official title: Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

• NCT number: NCT04829227
• Study type: Interventional
• Source: Sofwave Medical LTD
• Status: Completed
• Phase: Phase 3
• Start date: January 10, 2020
• Completion date: December 31, 2021