Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and t… (NCT04146584) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
United States93 participantsStarted 2019-11-20
Plain-language summary
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Who can participate
Age range35 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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 Epileptic seizures.
✕. History of severe migraine tendency.
✕. History of smoking in past 10 years.
What they're measuring
1
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
Timeframe: 3 months post last treatment follow up visit
2
Safety Investigator Assessments
Timeframe: 3 months post last treatment follow up visit