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Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04829227
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sofwave Medical LTD

Study Description
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Brief Summary:
Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Sofwave Phase 3

Detailed Description:
This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or 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. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. 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 visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Sofwave Treatment to Lift Lax Skin
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: face and/or neck and/or submental zones
the full face and/or neck and/or 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
 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.
Experimental: "off the face" areas
"off the face" areas: abdomen, or arms or thighs or Décolleté.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Improvements in lifting of lax tissue [ Time Frame: 3 and 6 months post last treatment ]
    as assessed by independent masked evaluators of pre and post treatment images.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829227


Contacts
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Contact: Ruthie Amir, MD +972-4-6432994 ruthie@sofwave.com
Contact: Shlomit Mann, MSc +972-4-6432994 shlomit@sofwave.com

Locations
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United States, New Jersey
SLSS, a Division of Schweiger Dermatology Group Research Office Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diana Aranzazu    201-951-0701    dianaa@skinandlasers.com   
Principal Investigator: David Goldberg, MD         
Sub-Investigator: Amy Tank, PA         
United States, Tennessee
The Practice of Brian S. Biesman, MD Recruiting
Nashville, Tennessee, United States, 37203
Contact: Amanda Spear, CCRC    615-329-1110    amanda@drbiesman.com   
Tennessee Clinical Research Center Active, not recruiting
Nashville, Tennessee, United States, 37215
United States, Virginia
McDaniel Institute of Aging Research Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Chris Mazur    757-417-8300    CMazur@miaar.com   
Sponsors and Collaborators
Sofwave Medical LTD
Investigators
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Study Director: Ruthie Amir, MD Sofwave
More Information
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Responsible Party: Sofwave Medical LTD
ClinicalTrials.gov Identifier: NCT04829227    
Other Study ID Numbers: Sofwave05
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: March 2021

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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
Keywords provided by Sofwave Medical LTD:
Laxity Brow Lifting Skin Saggy
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases