Actively Recruiting
Safety and Efficacy of SofWave 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study is an open-label, non-randomized, single-arm prospective trial designed to evaluate the safety and effectiveness of the SofWave system in lifting facial lax skin and improving facial wrinkles. The study includes adults aged 35 to 80 who desire cosmetic improvement of the face, neck, submental area, or eyebrow region. The study is conducted at multiple centers and includes masked evaluation of treatment effects. Participants will receive one or two treatments on the face, neck, or submental area using the SofWave device with either the Lift or Precise applicators. Treatments are spaced 2 to 12 weeks apart based on investigator discretion and site scheduling availability. Treatment may be given immediately after enrollment and screening or at a later scheduled date. Participants will attend a follow-up visit approximately three months after their last treatment to assess results. At each visit, efficacy and safety evaluations will be performed following the study protocol. The main outcome measured is the improvement in the appearance of skin laxity at the 3-month post-treatment visit. The total participation duration includes enrollment, treatment visits, and one follow-up visit.
CONDITIONS
Brief 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 eyebrow area and/or improve facial wrinkles
- Able and willing to comply with all visits, treatments, and evaluation schedules
- Able to understand and provide written informed consent
- Women of child-bearing age must use reliable birth control for at least 3 months prior to enrollment
- Agree not to undergo other facial cosmetic treatments for 3 months after last SofWave treatment
- Stable weight over the last 12 weeks and during the study
You will not qualify if you...
- Pregnant, planning pregnancy, recently gave birth (less than 3 months), or breastfeeding
- Active systemic or local infections
- Active local skin disease affecting wound healing
- Severe solar elastosis
- Current smoker or history of heavy smoking (25+ cigarettes/day) in past 10 years
- History of chronic drug or alcohol abuse
- Excessive subcutaneous fat on cheeks
- Significant scarring in treatment area
- Severe or cystic facial acne, or use of Accutane in past 6 months
- Metal stent or implant in facial area (dental implants/braces allowed)
- Unable to understand protocol or provide informed consent
- Recent cosmetic treatments in treatment area (facial skin-tightening, injectables, laser/light treatments, dermabrasion, peels, facelift, blepharoplasty, brow lift) within specified timeframes
- Use of isotretinoin or oral retinoids in past 6 months; anti-platelet or anti-coagulant use in past 2 weeks
- Any physical or mental condition making participation unsafe per investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Variable based on number and timing of treatments
Participants receive 1 to 2 face and/or neck and/or submental treatments using the SofWave system with the Lift and/or Precise applicators, spaced 2 to 12 weeks apart.
1 to 2 in-person treatment visits spaced 2 to 12 weeks apart
Duration - 3 months ± 2 weeks after last treatment
Participants return for one follow-up visit approximately 3 months after their last treatment to evaluate efficacy and safety.
1 follow-up visit (in-person)
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
R
Ruthie Amir, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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