Clinical trial NCT05987917: Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation
Official title: Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity.

Detailed description: 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 exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin for the examination of changes related to HA levels and photographs of the treated area will be taken.

The treatment administration phase in both treatment groups will consist of four (4) treatment visits, delivered 7 - 14 days apart.

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

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: