Wrinkle
Conditions
Brief summary
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.
Interventions
DEVICEBTL-785F
Radiofrequency
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale | 4 months | The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline. |
Countries
Bulgaria
Outcome results
None listed