Facial Wrinkles, Jawline Contour, Skin Laxity
Conditions
Keywords
lower face, upper neck, submental, facial wrinkles, jawline contour, skin laxity
Brief summary
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
DEVICESofWave
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues
Sponsors
Sofwave Medical LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female and male subjects between the ages 40-55. 2. Non-Smoker. 3. Fitzpatrick skin type I-VI. 4. Desire to lift facial lax skin, neck and/or submental and/or improve facial wrinkles appearance. 5. Presence of mild to moderate laxity in the lower face and submental area. 6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements. 7. Able to understand and provide written Informed Consent. 8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment. 9. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment. 10. Stable weight over the last 12 weeks and throughout the duration of the study. 11. Subjects agree to adhere to safe sun practices and daily use of broad-spectrum sunscreen SPF 30+. 12. Male subjects with facial hair in the treatment area are willing to trim or shave as needed to allow consistent standardized photography. \-
Exclusion criteria
1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. Presence of any active systemic or local infections. 3. Open wounds or lesions within the intended to treat area. 4. Tattoo or former tattoo at or near treatment area. 5. Presence of active local skin disease that may alter wound healing. 6. Uncontrolled diabetes mellitus. 7. 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). 8. Severe solar elastosis. 9. History of smoking in the past 10 years. 10. History of chronic drug or alcohol abuse. 11. Excessive subcutaneous fat on the cheeks. 12. Significant scarring in the area to be treated or history of keloids. 13. Severe or cystic facial acne, and/or Accutane use during the past 6 months. 14. Pacemakers and electronic device implants in the treated area. 15. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded). 16. Inability to understand the protocol or to provide a signed informed consent. 17. 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 18. Cosmetic surgical procedures in the treatment area, including but not limited to facelift in the past 12 months. 19. Taking anti-platelet or anti-coagulant within the past 2 weeks. 20. Ongoing use of psychiatric medication; taking psychiatric drugs within the past 2 weeks. 21. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation | 12 weeks post treatment follow-up visit | Rate of the Improvement in the appearance of lower face and upper neck rejuvenation following SofWave treatment based on Global Aesthetic Improvement Scale (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved) |
| Lower face and upper neck rejuvenation | 12 weeks post treatment follow-up visit | Evaluate the clinical efficacy of the treatment for lower face and upper neck rejuvenation, as assessed by the study physician using Physician Global Aesthetic Improvement Scale (GAIS; (-1=worse, 0=no change, 1=improved, 2=marked improvement, 3=very much improved)) at 12 weeks follow-up visit. |
Countries
United States
Contacts
CONTACTShlomit Mann, MSc
CONTACTRuthie Amir, MD
Outcome results
None listed