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 — DEVICE
    The 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

Locations (2)

FacilityCityStateZIPSite coordinators
Costal Skin & Eye InstituteLa MesaCalifornia91942
Christopher V.Crosby, MD
Christopher V.Crosby, MD (PRINCIPAL_INVESTIGATOR)
Skin Wellness Dermatology AssociatesDurhamNorth Carolina27713
Talasia Smith
(919) 294 9440
Brooke Jackson, MD (PRINCIPAL_INVESTIGATOR)

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