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

Completed · Not applicable

Conditions studied: Wrinkle

In brief

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.

Key facts

Study ID

NCT05525026

Run by

BTL Industries Ltd.

People needed

24

Starts

2021-12-08

Expected to finish

2023-02-15

Last updated by the study team

2023-04-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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