Back to resultsSafety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Primary Purpose
Skin Laxity, Wrinkle, Brow Lifting
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sofwave Treatments
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Skin Laxity, Submental, Neck, Brow Lifting, Laxity, 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 Epileptic seizures.
- History of severe migraine tendency.
- 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.
- Inability to understand the protocol or to give informed consent.
- On-going use of psychiatric medication.
- History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face within the past 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 psychiatric drugs, 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.
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Sites / Locations
- Laser & Skin Surgery Center of Northern California
- Laser & Skin Surgery Center of New York®
- New York Laser & Skin Care
- Dermatology, Laser & Vein Specialists of the Carolinas
- Dermatology & Laser Surgery Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sofwave Treatment
Arm Description
In this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck.
Outcomes
Primary Outcome Measures
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck & Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.
Safety Investigator Assessments
Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.
Secondary Outcome Measures
Efficacy Investigator Assessments
Evaluate investigator assessment of clinical improvement in the treated zones using the Physician Global Aesthetic Improvement Scale (PGAIS). In this scale the treating physician would have to select the proper answer regarding treatment efficacy out of 5 options ranging from: 1. Very Much Improved to 5. Worse. Each treated zone (Eyebrows, Neck & Submental) would be ranked individually.
Subject Efficacy Assessments
Evaluate patient assessment of clinical improvement in the treated zones and treatment satisfaction using the patient satisfaction questionnaire. The patient would be given a patient satisfaction questionnaire with three questions regarding overall improvement (scale of 5 options ranging from 0. Worse to 4. Very much improved ), overall satisfaction (scale of 5 options ranging from 0. Very Satisfied to 4. Very Unsatisfied) and a question regarding willing to participate in future studies (options of Yes, No, Not sure). Each treated zone (Eyebrows, Neck & Submental) would be ranked individually.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04146584
Brief Title
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Official Title
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 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
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
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Detailed Description
This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.
Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Wrinkle, Brow Lifting
Keywords
Skin Laxity, Submental, Neck, Brow Lifting, Laxity, Saggy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sofwave Treatment
Arm Type
Experimental
Arm Description
In this arm (single) patients would be treated twice with Sofwave on the face and/or submental and neck.
Intervention Type
Device
Intervention Name(s)
Sofwave Treatments
Intervention Description
The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.
Primary Outcome Measure Information:
Title
Efficacy Masked Evaluators Evaluations: assessed by independent masked evaluators
Description
Evaluate the clinical efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by independent masked evaluators. The two independent masked evaluators would be delivered a presentation with images randomly ordered for 'before' and 'after'. Each investigator would have to guess the correct 'after' image. Both investigators must agree on more than 50% of the cases to match success criteria. Each treated zone (Eyebrows, Neck & Submental) would be ranked individually. The primary endpoint would only be achieved along with success in outcome #5.
Time Frame
3 months post last treatment follow up visit
Title
Safety Investigator Assessments
Description
Evaluate the clinical safety of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow, as assessed by study physician. The investigator would examine the patient's skin before and after treatments and on follow up visits and would be requested to fill in a physician assessment, ranking Edema, erythema, ulceration/erosion, hypopigmentation and hyperpigmentation on a 5 option scale ranging from 0. - Absent to 4. Prominent. Safety would be checked every visit.
Time Frame
3 months post last treatment follow up visit
Secondary Outcome Measure Information:
Title
Efficacy Investigator Assessments
Description
Evaluate investigator assessment of clinical improvement in the treated zones using the Physician Global Aesthetic Improvement Scale (PGAIS). In this scale the treating physician would have to select the proper answer regarding treatment efficacy out of 5 options ranging from: 1. Very Much Improved to 5. Worse. Each treated zone (Eyebrows, Neck & Submental) would be ranked individually.
Time Frame
On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Title
Subject Efficacy Assessments
Description
Evaluate patient assessment of clinical improvement in the treated zones and treatment satisfaction using the patient satisfaction questionnaire. The patient would be given a patient satisfaction questionnaire with three questions regarding overall improvement (scale of 5 options ranging from 0. Worse to 4. Very much improved ), overall satisfaction (scale of 5 options ranging from 0. Very Satisfied to 4. Very Unsatisfied) and a question regarding willing to participate in future studies (options of Yes, No, Not sure). Each treated zone (Eyebrows, Neck & Submental) would be ranked individually.
Time Frame
On the second treatment visit date (pre treatment), 3 months post last treatment follow up visit
Other Pre-specified Outcome Measures:
Title
Quantitative Photo Analysis
Description
Photo analysis and measurements. Success criterion: point estimate of eyebrow lift > 0.5 mm Objective measurement of submental lift Success criterion: point estimate of submental lift > 20 mm. The primary endpoint would only be achieved along with success in outcome #5.
Time Frame
3 months post last follow up visit
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 Epileptic seizures.
History of severe migraine tendency.
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.
Inability to understand the protocol or to give informed consent.
On-going use of psychiatric medication.
History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face within the past 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 psychiatric drugs, 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
Avishai Tzur
Organizational Affiliation
Clinical Projects Manager
Official's Role
Study Chair
Facility Information:
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Laser & Skin Surgery Center of New York®
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Laser & Skin Care
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Dermatology, Laser & Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Dermatology & Laser Surgery Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
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