Summary

Eligibility
for people ages 35-80 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

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

Official Title

Safety and Efficacy of Sofacia Treatment to Improve Facial Lines and Wrinkles, to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Details

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).

Keywords

Skin Laxity Laxity Brow Lifting Skin Saggy Cutis Laxa Sofwave

Eligibility

You can join if…

Open to people ages 35-80

  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 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.

You CAN'T join if...

  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 braces are 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 facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 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.

Location

  • University of California accepting new patients
    Irvine California 92697 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sofwave Medical LTD
ID
NCT04969380
Phase
Phase 3
Study Type
Interventional
Last Updated