Clinical trial NCT04146584: Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Official title: Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Laxity
Wrinkle
Brow Lifting
Keywords: Skin Laxity
Submental
Neck
Brow Lifting
Laxity
Saggy
Lead sponsor: Sofwave Medical LTD
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 93
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).

Eligibility criteria: Inclusion Criteria:

1. Healthy female and male subjects between the ages 35-80.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to lift lax skin in the neck and submental and/or to lift the brows.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent
7. 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:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Severe solar elastosis.
5. History of Epileptic seizures.
6. History of severe migraine tendency.
7. History of smoking in past 10 years.
8. History of chronic drug or alcohol abuse.
9. Excessive subcutaneous fat on the cheeks.
10. Significant scarring in the area to be treated.
11. Severe or cystic facial acne, acutance uses during past 6 months.
12. Presence of a metal stent or implant in the facial area.
13. Inability to understand the protocol or to give informed consent.
14. On-going use of psychiatric medication.
15. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
16. Taking Isotretinoin or other oral retinoid within the past 6 months; taking psychiatric drugs, anti-platelet or anti-coagulant within the past 2 weeks.
17. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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Primary outcomes:
measure: Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
timeFrame: 3 months post last treatment follow up visit
measure: Safety Investigator Assessments
timeFrame: 3 months post last treatment follow up visit
Secondary outcomes:
measure: Efficacy Investigator Assessments
timeFrame: On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
measure: Subject Efficacy Assessments
timeFrame: On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Other outcomes:
measure: Quantitative Photo Analysis
timeFrame: 3 months post last follow up visit
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York®
state: New York
city: New York
country: United States
facility: New York Laser & Skin Care
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Houston
country: United States
facility: Dermatology & Laser Surgery Center
state: Texas
Study officials:
affiliation: Clinical Projects Manager
name: Avishai Tzur
role: STUDY_CHAIR
References: