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Treatment for Improvement of Cellulite Appearance Using Form Applicator

Primary Purpose

Cellulite

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sofwave
Sponsored by
Sofwave Medical LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulite focused on measuring upper thigh, buttock, skin laxity

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy female subjects > 18 years of age and < 60 years of age Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence. Have visible cellulite in the upper thigh and/or buttock areas. Seeking treatment of cellulite in the upper thigh and/or buttock areas. Stable weight nominally ±5% for at least past 6 months Subject agrees to maintain her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study course. Subject did not undergo invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months. Subject did not use topical based cellulite treatments for prior 6 months and will not use during the trial (except for the study related procedures) Subject agrees not to undergo any other cellulite treatments for a period of 3 months following SofWave treatment Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications, and presentations. Able and willing to comply with all visits, treatments and evaluations schedules and requirements. Able to understand and provide written Informed Consent. Exclusion Criteria: Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years BMI>=30kg/m2 Non-stable weight nominally ±5% for at least past 6 months Currently taking or has taken diet pills or weight control supplements within the past month History of severe migraine tendency History of Epileptic seizures History of chronic drug or alcohol abuse History of coagulopathy(ies) and/or on anticoagulant medication History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.) Active implanted device such as a pacemaker, defibrillator, cochlear implants, nerve/brain stimulators or drug delivery system Known allergy to lidocaine or epinephrine or antibiotics Active malignancy or history of malignancy in the past 5 years Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e., any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process) History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen History of significant lymphatic drainage problems History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Severe solar elastosis on the intended to treat area. Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising Tattoo or former tattoo at or near treatment area Presence of an implant (metal or plastic) in or adjacent to area of intended treatment (vascular stent, or implants in the hips, knees, etc) Inability to understand the protocol or to give informed consent On-going use of psychiatric medication Unable or unwilling to comply with the study requirements and procedures Unwilling to have research photos taken of treatment areas Currently enrolled in a clinical study of any other unapproved investigational drug or device Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject

Sites / Locations

  • Laser & Skin Surgery Center of Northern CaliforniaRecruiting
  • Schweiger Dermatology GP ResearchRecruiting
  • UnionDermRecruiting
  • Main Line Center for Laser SurgeryRecruiting
  • Tennessee Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cellulite

Arm Description

Outcomes

Primary Outcome Measures

Primary Outcome Measure:
Rate of improvement in the appearance of cellulite on the upper thigh/buttock area following Sofwave treatments based on 6 points simplified Cellulite Severity Scale (CSS), as evaluated by independent masked reviewers.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
September 21, 2023
Sponsor
Sofwave Medical LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05882721
Brief Title
Treatment for Improvement of Cellulite Appearance Using Form Applicator
Official Title
Safety and Efficacy of SofWave Treatment for Improvement of Cellulite Appearance Using
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (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 treatments (4 ± 2 weeks apart) on either one side (right or left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System with the Form applicator ('2X'). Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visit at 3 months ± 1 week post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
Keywords
upper thigh, buttock, skin laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cellulite
Arm Type
Experimental
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. Other Names: SUPERB
Primary Outcome Measure Information:
Title
Primary Outcome Measure:
Description
Rate of improvement in the appearance of cellulite on the upper thigh/buttock area following Sofwave treatments based on 6 points simplified Cellulite Severity Scale (CSS), as evaluated by independent masked reviewers.
Time Frame
3 months post treatment follow-up visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female subjects > 18 years of age and < 60 years of age Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence. Have visible cellulite in the upper thigh and/or buttock areas. Seeking treatment of cellulite in the upper thigh and/or buttock areas. Stable weight nominally ±5% for at least past 6 months Subject agrees to maintain her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the study course. Subject did not undergo invasive or energy-based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months. Subject did not use topical based cellulite treatments for prior 6 months and will not use during the trial (except for the study related procedures) Subject agrees not to undergo any other cellulite treatments for a period of 3 months following SofWave treatment Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications, and presentations. Able and willing to comply with all visits, treatments and evaluations schedules and requirements. Able to understand and provide written Informed Consent. Exclusion Criteria: Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding Currently heavy smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years BMI>=30kg/m2 Non-stable weight nominally ±5% for at least past 6 months Currently taking or has taken diet pills or weight control supplements within the past month History of severe migraine tendency History of Epileptic seizures History of chronic drug or alcohol abuse History of coagulopathy(ies) and/or on anticoagulant medication History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising Medical disorder that would hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.) Active implanted device such as a pacemaker, defibrillator, cochlear implants, nerve/brain stimulators or drug delivery system Known allergy to lidocaine or epinephrine or antibiotics Active malignancy or history of malignancy in the past 5 years Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e., any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process) History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen History of significant lymphatic drainage problems History of epidermal or dermal disorders (particularly involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Severe solar elastosis on the intended to treat area. Significant scarring, atrophic scars in the area to be treated, or has a history of atrophic scars or keloids or prone to bruising Tattoo or former tattoo at or near treatment area Presence of an implant (metal or plastic) in or adjacent to area of intended treatment (vascular stent, or implants in the hips, knees, etc) Inability to understand the protocol or to give informed consent On-going use of psychiatric medication Unable or unwilling to comply with the study requirements and procedures Unwilling to have research photos taken of treatment areas Currently enrolled in a clinical study of any other unapproved investigational drug or device Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomit Mann, MSc
Phone
+972-4-7800268
Email
Shlomit@sofwave.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruthie Amir, MD
Phone
+972-4-300-3164
Email
Ruthie@sofwave.com
Facility Information:
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Caselli, Site Manager
Phone
916-456-0400
Email
study@skinlasers.com
First Name & Middle Initial & Last Name & Degree
Suzanne Kilmer, MD
Facility Name
Schweiger Dermatology GP Research
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Aranzazu
Phone
201-951-0701
Email
Research@schweigerderm.com
First Name & Middle Initial & Last Name & Degree
David J. Goldberg, MD
Facility Name
UnionDerm
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Robinson
Phone
212-366-5400
Email
research@unionderm.com
First Name & Middle Initial & Last Name & Degree
Anne M. Chapas, MD
Facility Name
Main Line Center for Laser Surgery
City
Ardmore
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Plugis
Phone
610-645-5551
Email
jessderm@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eric Bernstein, MD
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra (Lexi) Worster
Phone
615-383-9660
Ext
173
Email
research@tnclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Treatment for Improvement of Cellulite Appearance Using Form Applicator

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