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Sofwave for Lifting Facial Lax Skin and Improving Wrinkles

This study is testing a device called Sofwave to see if it can help lift loose (lax) facial skin and reduce wrinkles. The Sofwave system uses high-intensity ultrasound energy delivered to the skin. We are looking for healthy men and women between 35 and 80 years old who do not smoke and want to improve the appearance of their facial skin, neck, or eyebrow area. The main goal is to see how much the appearance of lax skin improves three months after treatment. This study plans to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is an open-label, non-randomized study where all participants receive the Sofwave treatment. It is a single-arm study, meaning there is no comparison group, and it involves multiple centers.
What's involved
You would receive one or two treatments with the Sofwave system, 2 to 12 weeks apart. You will also have one follow-up visit about three months after your last treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about three months after their last treatment.

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NCT06333067

Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Recruiting
NAAges 35–80InterventionalTreatment
Sofwave Medical LTD
~100 participants
Updated 2025-05-13 on ClinicalTrials.gov
What's tested:Sofwave

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in the appearance of lax skin
Measured over 3 months post treatment follow-up visit

Conditions

Lax Skin

Explore related trials

Cutis Laxa

Where it's being run

2 sites across 2 states
California1
North Carolina1

Who to contact

Shlomit Mann, MSc
[email protected]
+972-4-7800268
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

1\. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.

What this trial measures

  • Improvement in the appearance of lax skin3 months post treatment follow-up visit

    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.