SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Last updated: November 16, 2023
Sponsor: Sofwave Medical LTD
Overall Status: Completed

Phase

N/A

Condition

Skin Aging

Treatment

Sofwave

Clinical Study ID

NCT04969380
UCI IRB HS# 2019-5520
  • Ages 35-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Open-label, non-randomized, 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 lax skin in the neck and submental and/or to lift the brows.
  5. Able and willing to comply with all visit, treatment 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 birth controlat least 3 months prior to study enrollment.

Exclusion

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. History of smoking in 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, acutance uses during past 6 months.
  10. Presence of a metal stent or implant in the facial area (dental implants and/or bracesare not excluded).
  11. Inability to understand the protocol or to give informed consent.
  12. History of cosmetic treatments in the facial area to be treated, including facialskin-tightening procedure within the 6 months ; injectable (Botox or fillers) of anytype within the 6 months; ablative or non-ablative resurfacing/rejuvenation lasertreatment or light treatment within the past 6 months, dermabrasion or deep facialpeels within the past 12 months; facelift, blepharoplasty, or brow lift (includingcontour threads) within the past 12 months.
  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 which mightmake it unsafe for the subject to participate in this study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Sofwave
Phase:
Study Start date:
February 27, 2020
Estimated Completion Date:
February 27, 2023

Study Description

Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and submental zones including 1. The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin.

All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).

Connect with a study center

  • University of California

    Irvine, California 92697
    United States

    Site Not Available

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