Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Facial Remodeling

April 11, 2023 updated by: BTL Industries Ltd.
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 facial remodeling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.

At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.

The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.

Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to every other procedure and at the follow-ups.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90212
        • Dr Bryan Kinney
    • Michigan
      • Birmingham, Michigan, United States, 48009
        • BOYD Beauty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male or female subjects over 21 years of age seeking treatment for facial remodeling
  • 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 sagging skin in the treated area when the face is relaxed 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
  • Isotretinoin and tretinoin-containing medication use in the past 12 months
  • Impaired immune system caused by any immunosuppressive illness, disease or medication
  • Skin related autoimmune diseases
  • Radiation therapy and/or chemotherapy
  • Poor healing and unhealed wounds in the treatment area
  • Metal implants1
  • 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)
  • 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 anti-aging or facelift 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 (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive facial remodeling
Treatment with the BTL-785-7 applicator to the BTL-785F system.
Treatment with the BTL-785-7 applicator to the BTL-785F system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive facial remodeling
Time Frame: 5 months
Evaluation of facial skin appearance based on photographs before and after the study procedure according to the Global Aesthetic Improvement Scale.The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy Comfort
Time Frame: 5 months
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).
5 months
Subject Satisfaction
Time Frame: 5 months
The Subject Satisfaction questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree".
5 months
Evaluation of skin quality and aesthetic change of the treated areas after the therapies
Time Frame: 5 months
Evaluation of skin quality and aesthetic change of the treated areas after the therapies based on photographs before and after the study procedure according to the Global Aesthetic Improvement Scale. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BTL-785_CTUS500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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