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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment
Precision Skin LLC
Davie, Florida, United States
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, United States
New Jersey Plastic Surgery (NJPS)
Montclair, New Jersey, United States
Gentile Facial Plastic and Aesthetic Laser Center
Youngstown, Ohio, United States
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.
Time frame: 15 months
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.
Time frame: 15 months
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.
Time frame: 15 months
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".
Time frame: 15 months
Change in the submental-cervical angle
Statistically significant change in submental-cervical angle (SCA) convexity in the majority of the subjects
Time frame: 15 months
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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.
Time frame: 15 months