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

Last updated: May 12, 2025
Sponsor: Sofwave Medical LTD
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Sofwave

Clinical Study ID

NCT06333067
Sofwave21
  • Ages 35-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 eyebrowarea and/or improve facial wrinkles appearance.

  5. Able and willing to comply with all visits, treatments and evaluation schedules andrequirements.

  6. Able to understand and provide written Informed Consent.

  7. Women of child-bearing age are required to be using a reliable method of birthcontrol at least 3 months prior to study enrollment.

  8. Subject agrees not to undergo any other facial cosmetic treatment for a period of 3months following last SofWave treatment.

  9. Stable weight over the last 12 weeks and throughout the duration of the study.

Exclusion

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth less than 3 monthsago, 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 ormore) 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/orbraces 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, includingfacial skin-tightening procedure within the past 6 months; injectable (Botox orfillers) of any type within the past 6 months; ablative or non-ablativeresurfacing/rejuvenation laser treatment or light treatment within the past 6months, dermabrasion or deep facial peels within the past 12 months; facelift,blepharoplasty, or brow lift (including contour threads) within the past 12months.

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

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Sofwave
Phase:
Study Start date:
October 11, 2023
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Costal Skin & Eye Institute

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Skin Wellness Dermatology Associates

    Durham, North Carolina 27713
    United States

    Active - Recruiting

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