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Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities.
All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1).
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lax tissue | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofwave | Device | The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the appearance of lax skin | Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers. | 3 months post treatment follow-up visit |
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Inclusion Criteria:
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. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.
6. History of chronic drug or alcohol abuse.
7. Excessive subcutaneous fat on the cheeks.
8. Significant scarring in the area to be treated.
9. Severe or cystic facial acne, and/or Accutane use during past 6 months.
10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
11. Inability to understand the protocol or to provide a signed informed consent.
12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type 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.
13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
14. 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shlomit Mann, MSc | Contact | +972-4-7800268 | Shlomit@sofwave.com | |
| Ruthie Amir, MD | Contact | +972-4-300-3164 | Ruthie@sofwave.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costal Skin & Eye Institute | Recruiting | La Mesa | California | 91942 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D019066 | Facies |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| Skin Wellness Dermatology Associates | Recruiting | Durham | North Carolina | 27713 | United States |
|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |