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Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Primary Purpose

Skin Laxity

Status

Completed

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

SLSS, a Division of Schweiger Dermatology Group Research Office
The Practice of Brian S. Biesman, MD
Tennessee Clinical Research Center
McDaniel Institute of Aging Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

face and/or neck and/or submental zones

"off the face" areas

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

"off the face" areas: abdomen, or arms or thighs or Décolleté.

Outcomes

Primary Outcome Measures

Improvements in lifting of lax tissue

as assessed by independent masked evaluators of pre and post treatment images.

Secondary Outcome Measures

Full Information

NCT ID

NCT04829227

First Posted

March 30, 2021

Last Updated

October 25, 2022

Sponsor

Sofwave Medical LTD

1. Study Identification

Unique Protocol Identification Number

NCT04829227

Brief Title

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Official Title

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

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 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

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.

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

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

face and/or neck and/or submental zones

Arm Type

Experimental

Arm Description

Arm Title

"off the face" areas

Arm Type

Experimental

Arm Description

"off the face" areas: abdomen, or arms or thighs or Décolleté.

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

Improvements in lifting of lax tissue

Description

as assessed by independent masked evaluators of pre and post treatment images.

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.

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

SLSS, a Division of Schweiger Dermatology Group Research Office

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

The Practice of Brian S. Biesman, MD

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Clinical Research Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

McDaniel Institute of Aging Research

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23462

Country

United States

12. IPD Sharing Statement

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Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

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