Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat

Not Applicable

Completed

• Conditions: Skin Laxity

• Registration Number: NCT05831332
• Lead Sponsor: BTL Industries Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Primary Completion: 2023-08-30
• Status Verified: 2023-10
• Study Completion: 2023-10-25
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of submental fat thickness	6 months	To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide reduction of submental fat thickness.

Secondary Outcome Measures

Name	Time	Method
Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat.	6 months	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.
Evaluation the effect on submental skin laxity	6 months	To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide improved skin laxity in the submental area.

Trial Locations

Locations (1)

Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova; 🇧🇬 Plovdiv, Bulgaria