BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement

BTL

Status

Completed

Conditions

Wrinkle

Treatments

Device: BTL-785-7

Study type

Interventional

Funder types

Industry

Identifiers

NCT05524779

BTL-785_CTUS1300

Details and patient eligibility

About

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 treatment of facial wrinkles.

Full description

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.

At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.

The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.

Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.

Enrollment

21 patients

Sex

All

Ages

21+ 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, 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)
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
Application in the area of chest, heart or over the eyes
Serious psychopathological disorders (such as schizophrenia)
Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
Blood vessels and lymphatic vessels inflammation