In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave Treatment

Part of paid clinical trials in San Diego, California.

Sponsor
Sofwave Medical LTD
Study ID
NCT07685821
Status
Active Not Recruiting

Conditions

  • Improve Facial Wrinkles
  • Lax Skin

Eligibility Criteria

Sex
ALL
Age
35 Years - 60 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. 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.

Study Details

Open-label, non-randomized single-arm prospective, single-center, self-controlled clinical study.

Key Dates

First listed
Jul 6, 2026
Start date
Dec 22, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lax tissue

Primary Outcome Measure

Evaluate the biological responses [ Time Frame: up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dermatology Cosmetic Laser Associates of La Jolla, IncSan DiegoCalifornia92121-

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Dermatology Cosmetic Laser Associates of La Jolla, Inc· San Diego, CA

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