Actively Recruiting
Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Led by Sofwave Medical LTD · Updated on 2025-05-13
100
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
CONDITIONS
Official Title
Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy female and male subjects between the ages 35-80
- Non-Smoker
- Fitzpatrick skin type I-VI
- Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance
- 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
You will not qualify if you...
- 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
- Presence of active local skin disease that may alter wound healing
- Severe solar elastosis
- Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) 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
- Severe or cystic facial acne, and/or Accutane use during past 6 months
- 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 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
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Costal Skin & Eye Institute
La Mesa, California, United States, 91942
Actively Recruiting
2
Skin Wellness Dermatology Associates
Durham, North Carolina, United States, 27713
Actively Recruiting
Research Team
S
Shlomit Mann, MSc
CONTACT
R
Ruthie Amir, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here