Treatment for Improvement of Cellulite Appearance Using Form Applicator

Completed · Not applicable

Conditions studied: Cellulite

In brief

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

Key facts

Study ID

NCT05882721

Run by

Sofwave Medical LTD

People needed

60

Starts

2023-02-20

Expected to finish

2023-11-15

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

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)
• 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

Where it is running

• Laser & Skin Surgery Center of Northern California — Sacramento, California, United States
• Schweiger Dermatology GP Research — Hackensack, New Jersey, United States
• UnionDerm — New York, New York, United States
• Main Line Center for Laser Surgery — Ardmore, Pennsylvania, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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