Treatment for Improvement of Cellulite Appearance Using Form Applicator

NCT05882721 | Completed FDA Device

• 1 other identifier: Sofwave19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Conditions

Cellulite

Keywords

upper thigh; buttock; skin laxity

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months post treatment follow-up visit

Study Arms (1)

Cellulite

EXPERIMENTAL

Device: Sofwave

Interventions

Sofwave DEVICE

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

Cellulite

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (5)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Schweiger Dermatology GP Research

Hackensack, New Jersey, 07601, United States

Location

UnionDerm

New York, New York, 10003, United States

Location

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Cellulite; Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: May 31, 2023
• Study Start: February 20, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-09

Locations

US (5)