SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Primary Purpose
Skin Laxity
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sofwave
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Laxity Brow Lifting Skin Saggy
Eligibility Criteria
Inclusion Criteria:
- Healthy female and male subjects between the ages 35-80.
- Non-Smoker.
- Fitzpatrick skin type I-VI.
- Desire to lift lax skin in the neck and submental and/or to lift the brows.
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- Able to understand and provide written Informed Consent
- 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:
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Presence of any active systemic or local infections.
- Presence of active local skin disease that may alter wound healing.
- Severe solar elastosis.
- History of smoking in past 10 years.
- History of chronic drug or alcohol abuse.
- Excessive subcutaneous fat on the cheeks.
- Significant scarring in the area to be treated.
- Severe or cystic facial acne, acutance uses during past 6 months.
- Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
- Inability to understand the protocol or to give informed consent.
- 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.
- Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
- As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Sites / Locations
- University of CaliforniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
face and/or neck and/or submental zones
Arm Description
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
Outcomes
Primary Outcome Measures
Change in lift of lax tissue
As assessed by independent masked evaluators. Quantitative image analysis to objectively measure change in lift of the eyebrow and submental and neck lax tissue would be conducted by comparing baseline images to those taken at each visit post FU1 (Pre Tx.2, FU2)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04969380
Brief Title
SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
February 27, 2023 (Anticipated)
Study Completion Date
February 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sofwave Medical LTD
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Laxity Brow Lifting Skin Saggy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
face and/or neck and/or submental zones
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Sofwave
Intervention Description
The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Primary Outcome Measure Information:
Title
Change in lift of lax tissue
Description
As assessed by independent masked evaluators. Quantitative image analysis to objectively measure change in lift of the eyebrow and submental and neck lax tissue would be conducted by comparing baseline images to those taken at each visit post FU1 (Pre Tx.2, FU2)
Time Frame
3 and 6 months post last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy female and male subjects between the ages 35-80.
Non-Smoker.
Fitzpatrick skin type I-VI.
Desire to lift lax skin in the neck and submental and/or to lift the brows.
Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
Able to understand and provide written Informed Consent
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:
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
Presence of any active systemic or local infections.
Presence of active local skin disease that may alter wound healing.
Severe solar elastosis.
History of smoking in past 10 years.
History of chronic drug or alcohol abuse.
Excessive subcutaneous fat on the cheeks.
Significant scarring in the area to be treated.
Severe or cystic facial acne, acutance uses during past 6 months.
Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
Inability to understand the protocol or to give informed consent.
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.
Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruthie Amir, MD
Phone
+972-4-6432994
Email
ruthie@sofwave.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomit Mann, MSc
Phone
+972-4-6432994
Email
shlomit@sofwave.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruthie Amir, MD
Organizational Affiliation
Sofwave
Official's Role
Study Director
Facility Information:
Facility Name
University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Mesinkovska, MD, PhD
Phone
949-824-7103
Email
dermresearch@uci.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
We'll reach out to this number within 24 hrs