Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

March 20, 2024 updated by: Sofwave Medical LTD

Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators.

Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities.

All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1).

Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Costal Skin & Eye Institute
        • Contact:
        • Principal Investigator:
          • Christopher V.Crosby, MD
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Recruiting
        • Skin Wellness Dermatology Associates
        • Contact:
        • Principal Investigator:
          • Brooke Jackson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy female and male subjects between the ages 35-80.
  2. Non-Smoker.
  3. Fitzpatrick skin type I-VI.
  4. Desire to lift facial lax skin, neck and/or submental and/or to lift the eyebrow area and/or improve facial wrinkles appearance.
  5. Able and willing to comply with all visits, treatments and evaluation schedules and requirements.
  6. Able to understand and provide written Informed Consent.
  7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.
  8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3 months following last SofWave treatment.
  9. Stable weight over the last 12 weeks and throughout the duration of the study.

Exclusion Criteria:

  • 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.

    2. Presence of any active systemic or local infections.

    3. Presence of active local skin disease that may alter wound healing.

    4. Severe solar elastosis.

    5. Currently a smoker or has a history of heavy smoking (25 cigarettes per day or more) in the past 10 years.

    6. History of chronic drug or alcohol abuse.

    7. Excessive subcutaneous fat on the cheeks.

    8. Significant scarring in the area to be treated.

    9. Severe or cystic facial acne, and/or Accutane use during past 6 months.

    10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).

    11. Inability to understand the protocol or to provide a signed informed consent.

    12. 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.

    13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.

    14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lax tissue
Device: Sofwave
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Other Names:
  • SUPERB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: 3 months post treatment follow-up visit
Rate of improvement in the appearance of lax skin on the submental, neck zones and facial wrinkles following Sofwave treatments based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers.
3 months post treatment follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sofwave Medical LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sofwave21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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