Treatment for Cellulite Appearance

NCT05358847 | Completed FDA Device

• 1 other identifier: Sofwave08
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 4

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)

• 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.

Also known as: 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 6 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 (4)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

UnionDerm

New York, New York, 10003, United States

Location

Laser & Skin Surgery Center of New York®

New York, New York, 10016, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, 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: April 27, 2022
• First Posted: May 3, 2022
• Study Start: November 21, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-04

Locations

US (4)