Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids

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).

Inclusion criteria

• 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 criteria

• 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.