RecruitingNot Applicable

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

United States100 participantsStarted 2023-10-11

Plain-language summary

Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.

Age range35 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
✓. Able to understand and provide written Informed Consent.
✓. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
✓. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.

Improvement in the appearance of lax skin

Timeframe: 3 months post treatment follow-up visit

NCT IDNCT06333067

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-01

Shlomit Mann, MSc