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

PHASE2CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

November 20, 2019

Primary Completion Date

March 30, 2021

Study Completion Date

March 30, 2021

Conditions
Skin LaxityWrinkleBrow Lifting
Interventions
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.

Trial Locations (5)

10016

Laser & Skin Surgery Center of New York®, New York

10028

New York Laser & Skin Care, New York

28207

Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte

77030

Dermatology & Laser Surgery Center, Houston

95816

Laser & Skin Surgery Center of Northern California, Sacramento

All Listed Sponsors
lead

Sofwave Medical LTD

INDUSTRY

NCT04146584 - Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow | Biotech Hunter | Biotech Hunter