Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face

BTL

Status

Completed

Conditions

Wrinkle

Treatments

Device: BTL-785-7

Study type

Interventional

Funder types

Industry

Identifiers

NCT05524662

BTL-785_CTUS900

Details and patient eligibility

About

This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and overall improvement of facial appearance.

Full description

The changes in the skin related to the connective tissue structural proteins (i. e. elastin and collagen fibers) will be assessed histologically. The study is a prospective, single-center, two-arm, open-label study. The subjects will be enrolled and assigned into two groups; Group A (RF & EMF) and Control group, which will not receive any treatment.

At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin (preauricular area) for the examination of changes related to skin's connective tissue, and photographs of the treated area will be taken.

The treatment administration phase in the treatment group will consist of four (4) treatment visits, delivered 5-10 days apart.

Enrollment

7 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 and overall aesthetic improvement of the face
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 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, to undergo punch biopsies and to have photographs of their face taken

Exclusion criteria

Bacterial or viral infection, acute inflammations ,
Impaired immune system
Isotretinoin in the past 12 months
Skin related autoimmune diseases
Radiation therapy and 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 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
Electroanalgesia without exact diagnosis of pain etiology
Serious psychopathological disorders (such as schizophrenia)
Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
Blood vessels and lymphatic vessels inflammation