CompletedPhase 3

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

United States45 participantsStarted 2020-01-10

Plain-language summary

Open-label, non-randomized 2 arms 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 lax skin in the neck and submental and/or to lift the brows.
✓. Able and willing to comply with all visit, treatment 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.

✕. 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.
✕. Presence of active local skin disease that may alter wound healing.
✕. Severe solar elastosis.
✕. History of smoking in past 10 years.
✕. History of chronic drug or alcohol abuse.
✕. Excessive subcutaneous fat on the cheeks.
✕. Significant scarring in the area to be treated.

Improvements in lifting of lax tissue

Timeframe: 3 and 6 months post last treatment

NCT IDNCT04829227

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31