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

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

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator 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 three (3) treatment visits and two follow-up visits. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Follow-ups visits at 3 months and 6 months after the final treatment will be held.

Inclusion Criteria:

• Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial 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 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/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 6 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
• Acute neuralgia and neuropathy
• Kidney or liver failure
• Sensitivity disorders in the treatment area
• Varicose veins, pronounced edemas
• 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 ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
• Unwillingness/inability to abstain from cosmetic procedures in the treated area at least 15 days before every examination with the facial image analysis system VISIA
• Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study