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SofWave for Skin Aging

SM
RA
Overseen ByRuthie Amir, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Sofwave Medical LTD
Must not be taking: Accutane, Psychiatric drugs, Anti-coagulants, others
Disqualifiers: Pregnancy, Infections, Diabetes, Smoking, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Non-randomized single-arm prospective clinical study.

Are You a Good Fit for This Trial?

This trial is for adults with loose skin, droopy eyelids, or wrinkles on the lower face or neck who want cosmetic improvement. People with certain medical conditions or contraindications may not be eligible.

Inclusion Criteria

I have mild to moderate looseness in my lower face or under my chin.
Able and willing to comply with all visits, treatments and evaluation schedules and requirements
Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+
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Exclusion Criteria

Tattoo or former tattoo at or near treatment area
As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible subjects will receive 1 or 2 SofWave treatments using the Total Treatment Energy (TTE) methods

4-6 weeks
1 or 2 visits (in-person)

Follow-up

Participants return for follow-up visits to monitor the efficacy and safety of the treatment

24 weeks
3 visits (in-person) at 4, 12, and 24 weeks post last treatment

What Are the Treatments Tested in This Trial?

Interventions

  • SofWave

Trial Overview

The study is testing SofWave, a device that uses ultrasound energy to tighten and rejuvenate skin on the lower face and neck. All participants receive the treatment; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental: lax tissueExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sofwave Medical LTD

Lead Sponsor

Trials
11
Recruited
640+

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