Improve Facial Wrinkles, Lax Skin
Conditions
Keywords
wrinkles, Lax Skin, Neck, Submental, Lifting
Brief summary
Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study.
Detailed description
Eligible subjects will arrive for a screening visit, and if will be found eligible and will provide signed ICF, during this visit a biopsy will be taken from the pre-auricular area. At the second visit, a week after the screening visit, sutures from the biopsy (if present) will be removed, and subjects will receive a single treatment on the full face, neck, and submental area using the SofWave system with the Lift applicator. Subjects will return to the clinic for a follow-up visit at one of the following timepoints (2 subjects per timepoint): 5 days, 4 weeks ± 2 days, 8 weeks ± 2 days, 12 weeks ± 4 days, or 24 weeks ± 4 days post-treatment. During this visit, an additional biopsy will be taken from the opposite pre-auricular side to that used at the screening visit. All subjects will arrive for an additional visit, a week after the follow-up visit, for suture removal (if will exist).
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. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
Sponsors
Sofwave Medical LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female and male subjects between the ages 35-60 2. Non-Smoker. 3. Fitzpatrick skin type I-VI. 4. Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance. 5. Willing to give biopsies. 6. Able and willing to comply with all visits, treatments and evaluation schedules and requirements (including providing biopsies). 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.
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. Presence of active local skin disease that may alter wound healing. 4. Severe solar elastosis. 5. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years. 6. History of chronic drug or alcohol abuse. 7. Excessive subcutaneous fat on the cheeks. 8. Significant scarring in the area to be treated. 9. Severe or cystic facial acne, and/or Accutane use during past 6 months. 10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded). 11. Inability to understand the protocol or to provide a signed informed consent. 12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past 6 months; injectable (Botox or fillers) of any type within the past 6 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, blepharoplasty, or brow lift (including contour threads) within the past 12 months. 13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks. 14. 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 biological responses | up to 24 weeks | Evaluate the biological responses of tissue inflammation, proliferation and remodeling via fibroblast stimulation following SofWave single treatment. Tissue biological responses will be correlated with the patients' skin laxity and global aesthetic improvement. |
Countries
United States
Outcome results
None listed