Fat Burn Clinical Trial
Official title:
Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation
Verified date | February 2024 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 18, 2023 |
Est. primary completion date | October 31, 2023 |
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 undergo punch biopsy of the submental area 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) - 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 edemas - 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 | Schweiger Dermatology PC, Research Division | Hackensack | New Jersey |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue. | Histological observation of morphological changes in the submental subcutaneous fat tissue post-treatment in the biopsies obtained from treatment and control group. | 6 months | |
Secondary | Investigation of post-treatment adipocyte apoptosis | Histologically analyze the adipocyte tissue for the change in apoptosis markers (caspase-3/7 and Bcl-2) levels. | 6 months | |
Secondary | Incidence of Treatment-related Adverse Events | Evaluation of the safety of the BTL-785F device with BTL-785-7 applicator for non-invasive treatment of the submental area throught monitoring of adverse events | 6 months | |
Secondary | Comfort Evaluation Assessed by Therapy Comfort Questionnaire | Evaluation of therapy comfort using the 5-point Likert scale Therapy Comfort Questionnaire given to subjects after the treatment, where the best possible answer would be "strongly agree" and the worst "strongly disagree". The questionnaire includes pain sensation rating on the scale from 0 (no pain) to 10 (worst possible pain), where 0 (no pain) represents the best possible outcome. | 6 months |
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