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

Completed · Not applicable

Conditions studied: Rhytides, Wrinkle

In brief

Open-label, non-randomized, prospective, multi-center, self-controlled

Key facts

Study ID

NCT06104514

Run by

Sofwave Medical LTD

People needed

60

Starts

2023-07-01

Expected to finish

2025-05-12

Last updated by the study team

2025-05-15

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Premier Plastic Surgery — Palo Alto, California, United States
• Cosmetic Laser Dermatology — San Diego, California, United States
• Advanced dermatoloy — Lincolnshire, Illinois, United States
• Aesthetic Revolution Las Vegas — Las Vegas, Nevada, United States
• New Jersey Plastic Surgeon — Montclair, New Jersey, United States
• UnionDerm — New York, New York, United States

Full record on ClinicalTrials.gov

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