Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-55
SponsorSofwave Medical LTD
About this trial
Non-randomized single-arm prospective clinical study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy female and male subjects between the ages 40-55.
Non-Smoker.
Fitzpatrick skin type I-VI.
Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
Disqualifiers
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
Presence of any active systemic or local infections.
Open wounds or lesions within the intended to treat area.
Tattoo or former tattoo at or near treatment area.
Trial design
Design model
Single group
Treatments tested in this trial
SofWave
DeviceThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental: lax tissueExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation
Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)
Time frame
12 weeks post treatment follow-up visit2
Lower face and upper neck rejuvenation
Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit.
Time frame
12 weeks post treatment follow-up visitSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: