Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue

Fat Burn Clinical Trial

Official title:

Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06282172
• Other study ID #: BTL-785_CTUS1600
• Status: Completed
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: December 18, 2023

Study information

• Verified date: February 2024
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. The changes in the fat tissue related to the morphology (shape, size and count) will be assessed histologically. The presence of biochemical apoptotic indicators will be analysed in the adipocytes.

The study is a prospective single-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment (5 subjects) and Group B (2 subjects), will serve as the control, and will not receive any treatment to verify the treatment outcomes.

Subjects will be required to complete one (1) treatment visit and three (3) follow-up visits (at 24 hours, 7 days and 14 days post treatment). The third follow-up visit is for safety evaluation.

At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.

Punch biopsies (3mm diameter) will be obtained from the treatment area for histologic analysis. In the control group, biopsy will be obtained from the location corresponding to the treatment area in the active group.

Safety measures will include documentation of adverse events (AE) during and after the treatment procedures and at the follow up visits and if needed medical assistance.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fat Burn

Intervention

Device:
• Treatment with BTL-785-7
Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area

Locations

Country	Name	City	State
United States	Schweiger Dermatology PC, Research Division	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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