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

NCT05525026 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS500
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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 facial remodeling.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Non-invasive facial remodeling

  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 Outcomes (3)

• Evaluation of skin quality and aesthetic change of the treated areas after the therapies

  5 months

• Subject Satisfaction

  5 months

• Therapy Comfort

  5 months

Study Arms (1)

Non-invasive facial remodeling

EXPERIMENTAL

Treatment with the BTL-785-7 applicator to the BTL-785F system.

Device: BTL-785-7

Interventions

BTL-785-7 DEVICE

Treatment with the BTL-785-7 applicator to the BTL-785F system.

Non-invasive facial remodeling

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Dr Bryan Kinney

Beverly Hills, California, 90212, United States

Location

BOYD Beauty

Birmingham, Michigan, 48009, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: December 8, 2021
• Primary Completion: November 30, 2022
• Study Completion: February 15, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)