Skin Laxity Clinical Trial
Official title:
Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Submental Fat
Verified date | October 2023 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 reduction of submental fat and skin laxity treatment.
Status | Completed |
Enrollment | 56 |
Est. completion date | October 25, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat - 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 excess fat in submentum 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 fat reduction, 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova | Plovdiv |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of submental fat thickness | To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide reduction of submental fat thickness. | 6 months | |
Secondary | Evaluation the effect on submental skin laxity | To gather clinical evidence that BTL-785F system equipped with BTL-785-7 applicator is able to provide improved skin laxity in the submental area. | 6 months | |
Secondary | Evaluation the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat. | To evaluate the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat through monitoring of adverse reactions. | 6 months |
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