Status:
COMPLETED
Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids
Lead Sponsor:
Sofwave Medical LTD
Conditions:
Rhytides
Wrinkle
Eligibility:
All Genders
35-80 years
Phase:
NA
Brief Summary
Open-label, non-randomized, prospective, multi-center, self-controlled
Detailed Description
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-FU2).
Eligibility Criteria
Inclusion
- Healthy female and male subjects between the ages 35-80.
- Desire to improve the peri-oral appearance, decrease the distance between the nose and the upper lip (Philtral column length) and/or reduce the peri-oral rhytids.
- Philtral column height\>15mm or/and has moderate severe perioral rhytids.
- Subject agrees to maintain a stable weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- Able to understand and provide written Informed Consent.
- Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
- Agree not to undergo any other facial treatments for a period of 3 months following SofWave treatments.
- 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
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- Melanoma active malignancy or history of malignancy in the past 5 years.
- Any other non-melanoma malignancy active malignancy or history of malignancy in the past 5 years within the intended to treat area.
- Previous chemotherapy treatments.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
- History of chronic drug or alcohol abuse
- History of Epileptic seizures.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
- History of significant lymphatic drainage problems within the facial areas.
- History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
- Excessive subcutaneous fat on the face.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-coagulant within the past 2 weeks
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Non-stable weight ( ±5%) within the past month.
- Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- Known allergy to Lidocaine, Tetracaine, Xylocaine, Epinephrine or antibiotics.
- Skin disorders (skin systematic or local infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
- Severe solar elastosis at the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Tendency for Melasma inflammation.
- Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising.
- Surgical or traumatic scar in the intended to treat area.
- Presence of a metal stent or implant in the facial area (e.g. braces; dental implants are not excluded).
- History of cosmetic treatments in the facial area to be treated, including blepharoplasty, direct specific forehead lift and facial skin-tightening procedure within the 6 months;injectable (Botox or fillers) of any type within the 12 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 or neck lift within the past 12 months.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06104514
Start Date
July 1 2023
End Date
May 12 2025
Last Update
May 15 2025
Active Locations (6)
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1
Premier Plastic Surgery
Palo Alto, California, United States, 94306
2
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San Diego, California, United States, 92121
3
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Lincolnshire, Illinois, United States, 60069
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Aesthetic Revolution Las Vegas
Las Vegas, Nevada, United States, 89148