Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles

BTL

Status

Completed

Conditions

Wrinkle

Treatments

Device: BTL-785F

Study type

Interventional

Funder types

Industry

Identifiers

NCT05476211

BTL-785_CTBG100

Details and patient eligibility

About

This study will evaluate the clinical safety and the performance of the BTL-785F system for non-invasive treatment of facial wrinkles. The study is a multicenter 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.

Enrollment

46 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles
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 wrinkles in the treated areas (forehead, cheeks) 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
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
Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)1
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 edemas1
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 anti-wrinkles 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 at the investigator discretion that may pose risk to the patient or compromise the study