Clinical trial NCT06274177: Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation
Official title: Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Keywords: submentum
neck rejuvenation
double chin
fat
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: This is a multi center single-arm, open-label, interventional study.

The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.

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

The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.

At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.

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

Eligibility criteria: 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

Primary outcomes:
measure: Submental fat thickness reduction
timeFrame: 15 months
Secondary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: 15 months
measure: Change on the Clinician Reported - Submental Fat Rating Scale score
timeFrame: 15 months
measure: Satisfaction Assessed by the Satisfaction Questionnaire
timeFrame: 15 months
measure: Change in the submental-cervical angle
timeFrame: 15 months
measure: Comfort Assessed by Therapy Comfort Questionnaire
timeFrame: 15 months
Other outcomes:
Locations:
city: Davie
country: United States
facility: Precision Skin LLC
state: Florida
city: Chicago
country: United States
facility: Chicago Cosmetic and Dermatologic Research
state: Illinois
city: Montclair
country: United States
facility: New Jersey Plastic Surgery (NJPS)
state: New Jersey
city: Youngstown
country: United States
facility: Gentile Facial Plastic and Aesthetic Laser Center
state: Ohio
Study officials:
References: