BTL-785F Device for Improving the Structure of Facial Muscles

NCT05524740 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS1200
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 and investigate its effect on muscles and wrinkles.

Conditions

Wrinkle

Keywords

wrinkle; muscle tone; skin laxity

Outcome Measures

Primary Outcomes (1)

• Aesthetic Improvement of the Face

  Three independent evaluators will review the photographs of treated areas for facial firming and lifting improvement (left and right cheeks and the forehead), and will provide an overall GAIS score. In other words, the reviewers will score the aesthetic improvement regarding the facial remodeling for the whole face. 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 (2)

• Therapy Comfort

  5 months

• Subject Satisfaction

  5 months

Study Arms (1)

BTL-785-7 Treatment

EXPERIMENTAL

Treatment with BTL-785F device (BTL-785-7 applicator)

Device: BTL-785-7

Interventions

BTL-785-7 DEVICE

Treatment with the BTL-785F device with the BTL-785-7 applicator for improvement of the structure of facial muscles.

BTL-785-7 Treatment

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
• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Yael Halaas, M.D., FACS

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

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: June 27, 2022
• Primary Completion: December 10, 2022
• Study Completion: May 23, 2023
• Last Updated: July 18, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)