Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
ConditionLax Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorSofwave Medical LTD
About this trial
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy female and male subjects between the ages 35-80.
Non-Smoker.
Fitzpatrick skin type I-VI.
Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
Disqualifiers
1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
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
100 Participants
are divided into 1 treatment groupGroup A: lax tissueExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in the appearance of lax skin
Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.
Time frame
3 months post treatment follow-up visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov