NCT04146584

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.

Detailed description

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow. Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).

Conditions

• Skin Laxity
• Wrinkle
• Brow Lifting

Interventions

Type	Name	Description
DEVICE	Sofwave Treatments	The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2019-10-31
• Last updated: 2021-07-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study