Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation

Launched by BTL INDUSTRIES LTD. · Aug 4, 2023

Keywords

ClinConnect Summary

The changes in the skin tissue related to the levels of hyaluronic acid (HA) will be assessed histologically. The study is a prospective, single-center, three-arm, open-label study. The subjects will be enrolled and assigned into two treatment groups; group A (RF \& USN) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. Additionally, a Control will be included to verify the treatment outcomes.

At the baseline visit, health status will be assessed. Inclusion and exc...

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Healthy male or female subjects over 21 years of age seeking treatment with non-invasive radiofrequency and ultrasound treatment for facial rejuvenation
• • Subjects should be able to 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 undergo punch biopsies in the infraauricular area.
• • Agreement to have their photographs taken for the purpose of this clinical investigation.
• • 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 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
• • 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 anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
• • Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
• • Any disease or condition contradicting the skin tissue biopsy
• • Any disease or condition that may compromise the histologic observation at the pathologist discretion