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SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Skin Laxity Clinical Trial

Official title:
Safety and Efficacy of Sofacia Treatment to Improve Facial Lines and Wrinkles, to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Clinical Trial Summary

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

Clinical Trial Description

Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and 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. All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04969380
Study type Interventional
Source Sofwave Medical LTD
Contact
Status Completed
Phase N/A
Start date February 27, 2020
Completion date February 27, 2023
View Details
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