Not yet recruiting NCT07723664
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SofWave.
- Who it may be relevant to
- Registry conditions: Facial Wrinkles, Jawline Contour, Skin Laxity. Basic parameters: 40 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Non-randomized single-arm prospective clinical study.
Detailed description
Eligible subjects will receive 1 or 2 SofWave treatments (4-6 weeks apart) using the Total Treatment Energy (TTE) methods and will return to 3 follow up visits: at 4 weeks ± 2 weeks post last treatment (FU1), at 12 weeks ± 2 weeks post last treatment (FU2) , at 24 weeks ± 4 weeks post last treatment (FU3).
Interventions
- Device SofWave
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues
Primary outcome measures
- Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation [Time frame: 12 weeks post treatment follow-up visit]
- Lower face and upper neck rejuvenation [Time frame: 12 weeks post treatment follow-up visit]
Eligibility criteria
Inclusion criteria
- Healthy female and male subjects between the ages 40-55.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance.
- Presence of mild to moderate laxity in the lower face and submental area.
- Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
- Able to understand and provide written Informed Consent.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
- Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
- Stable weight over the last 12 weeks and throughout the duration of the study.
- Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+.
- Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography.
\-
Exclusion criteria
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Presence of any active systemic or local infections.
- Open wounds or lesions within the intended to treat area.
- Tattoo or former tattoo at or near treatment area.
- Presence of active local skin disease that may alter wound healing.
- Uncontrolled diabetes mellitus.
- Skin cancer in the area to be treated. History of any other non-melanoma skin cancers in the past 5 years within the treatment area (head and neck).
- Severe solar elastosis.
- History of smoking in the past 10 years.
- History of chronic drug or alcohol abuse.
- Excessive subcutaneous fat on the cheeks.
- Significant scarring in the area to be treated or history of keloids.
- Severe or cystic facial acne, and/or Accutane use during the past 6 months.
- Pacemakers and electronic device implants in the treated area.
- Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- Inability to understand the protocol or to provide a signed informed consent.
- History of cosmetic treatments in the area to be treated including:
- Chemical peels, microneedling, dermabrasion, energy-based devices, or laser treatments in the past 6 months
- Injectable filler treatments in the past 6 months
- Injectable neuromodulator treatment in the past 4 months
- Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months.
- Taking anti-platelet or anti-coagulant within the past 2 weeks.
- Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks.
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dermatology & Laser Surgery Center — Houston
Identifiers
NCT: NCT07723664 · SofWave31