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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

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring Laxity Brow Lifting Skin Saggy

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT04969380

First Posted

July 7, 2021

Last Updated

October 25, 2022

Sponsor

Sofwave Medical LTD

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

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

ruthie@sofwave.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shlomit Mann, MSc

Phone

+972-4-6432994

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

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

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