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

NCT06104514 | Completed FDA Device

• 1 other identifier: Sofwave20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Rhytides; Wrinkle

Keywords

upper lip, peri-oral, philtral

Outcome Measures

Primary Outcomes (1)

• Rate of improvement in the appearance of upper lip and peri-oral rhytids

  Study will be considered a success if more than 50% of the subjects will have an improvement according to investigators' assessments of pre- and post Treatment 2D images

  12 weeks post last treatment

Study Arms (1)

Lift the upper lip and improve the peri-oral rhytids

EXPERIMENTAL

Device: Sofwave

Interventions

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.

Also known as: SUPERB

Lift the upper lip and improve the peri-oral rhytids

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (6)

Premier Plastic Surgery

Palo Alto, California, 94306, United States

Location

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Advanced dermatoloy

Lincolnshire, Illinois, 60069, United States

Location

Aesthetic Revolution Las Vegas

Las Vegas, Nevada, 89148, United States

Location

New Jersey Plastic Surgeon

Montclair, New Jersey, 07042, United States

Location

UnionDerm

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Lymphoid Interstitial Pneumonia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: July 1, 2023
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (6)