Fat Burn Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation
Verified date | February 2024 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.
Status | Active, not recruiting |
Enrollment | 37 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat - Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form - Presence of clearly visible excess fat in submentum as deemed appropriate by the Investigator - Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation - Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken Exclusion Criteria: - Local bacterial or viral infection in the area to be treated - Local acute inflammation in the area to be treated - Impaired immune system caused by any immunosuppressive illness, disease or medication - Isotretinoin and tretinoin-containing medication use in the past 12 months - Skin related autoimmune diseases - Radiation therapy and/or chemotherapy - Poor healing and unhealed wounds in the treatment area - Metal implants - Permanent implant in the treated area - Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body - Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment - Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles - History of skin disorders, keloids, abnormal wound healing and dry or fragile skin - History of any type of cancer - Active collagen diseases - Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, hypersensitive carotid sinus and thrombosis)1 - Pregnancy/nursing or IVF procedure - History of bleeding coagulopathies, use of anticoagulants - Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea - Any surgical procedure in the treatment area within the last three months or before complete healing - Poorly controlled endocrine disorders, such as diabetes - Acute neuralgia and neuropathy - Kidney or liver failure - Nerve insensitivity (sensitivity disorders) to heat in the treatment area - Varicose veins, pronounced edemas1 - Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion - Unwillingness/inability to not change their usual cosmetics and especially not to use fat reduction, anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period - Electroanalgesia without exact diagnosis of pain etiology - Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy) - Blood vessels and lymphatic vessels inflammation - Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study |
Country | Name | City | State |
---|---|---|---|
United States | Chicago Cosmetic and Dermatologic Research | Chicago | Illinois |
United States | Precision Skin LLC | Davie | Florida |
United States | New Jersey Plastic Surgery (NJPS) | Montclair | New Jersey |
United States | Gentile Facial Plastic and Aesthetic Laser Center | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Submental fat thickness reduction | The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 mm in the average submental fat layer thickness in the majority of subjects measured by MRI at 3-months follow-up compared to baseline. | 15 months | |
Secondary | Incidence of Treatment-related Adverse Events | To evaluate the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat through monitoring of adverse reactions. | 15 months | |
Secondary | Change on the Clinician Reported - Submental Fat Rating Scale score | Evaluation of the change in the Clinician Reported - Submental Fat Rating Scale (CR-SMFRS) grade. The scale ranges from grade 0 (no evident submental fat) to grade 4 (extreme submental convexity). Photographs from the last therapy, 1 month and 3 months follow-up will be compared to baseline photographs. An improvement is considered a decrease of the grade in the Clinician Reported - Submental Fat Rating Scale. | 15 months | |
Secondary | Satisfaction Assessed by the Satisfaction Questionnaire | The 5-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' under-chin and overall facial appearance will vary from "strongly agree" to "strongly disagree". | 15 months | |
Secondary | Change in the submental-cervical angle | Statistically significant change in submental-cervical angle (SCA) convexity in the majority of the subjects | 15 months | |
Secondary | Comfort Assessed by Therapy Comfort Questionnaire | The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). The Therapy Comfort questionnaire will be given to subjects after the last therapy. | 15 months |
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