Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Part of paid clinical trials in La Mesa, California.
- Sponsor
- Sofwave Medical LTD
- Study ID
- NCT06333067
- Status
- Recruiting
Conditions
- Lax Skin
Eligibility Criteria
- Sex
- ALL
- Age
- 35 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- Sofwave — DEVICEThe Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Study Details
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Key Dates
- Start date
- Oct 11, 2023
- Status verified
- May 2025
- Primary completion
- Oct 1, 2025
- Completion
- Nov 1, 2025
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: lax tissue
Primary Outcome Measure
Improvement in the appearance of lax skin [ Time Frame: 3 months post treatment follow-up visit ]
Central Contacts
- Shlomit Mann, MSc+972-4-7800268
- Ruthie Amir, MD+972-4-300-3164
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Costal Skin & Eye Institute | La Mesa | California | 91942 | Christopher V.Crosby, MD Christopher V.Crosby, MD (PRINCIPAL_INVESTIGATOR) |
| Skin Wellness Dermatology Associates | Durham | North Carolina | 27713 | Brooke Jackson, MD (PRINCIPAL_INVESTIGATOR) |
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