Clinical trial NCT05524662: Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face
Official title: Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and overall improvement of facial appearance.

Detailed description: The changes in the skin related to the connective tissue structural proteins (i. e. elastin and collagen fibers) will be assessed histologically. The study is a prospective, single-center, two-arm, open-label study. The subjects will be enrolled and assigned into two groups; Group A (RF \& EMF) and Control group, which will not receive any treatment.

At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin (preauricular area) for the examination of changes related to skin's connective tissue, and photographs of the treated area will be taken.

The treatment administration phase in the treatment group will consist of four (4) treatment visits, delivered 5-10 days apart.

Eligibility criteria: 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, to undergo punch biopsies 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)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
* Electroanalgesia without exact diagnosis of pain etiology
* Serious psychopathological disorders (such as schizophrenia)
* Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
* Blood vessels and lymphatic vessels inflammation

Primary outcomes:
measure: Histological examination
timeFrame: 5 months
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 5 months
measure: Therapy Comfort
timeFrame: 5 months
measure: Evaluation of Wrinkle Severity
timeFrame: 5 months
measure: Evaluation of Overall Facial Appearance According to GAIS
timeFrame: 5 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Schweiger Dermatology PC, Reseach Division
state: New Jersey
Study officials:
References: