BTL-785F Device for Non-invasive Reduction of Wrinkles

Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles

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 treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: BTL-785-7

Detailed Description

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 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.

At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.

The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.

Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.

Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Yael Halaas M.D.
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Gentile Facial Plastic Surgery & Aesthetic Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 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 medication1
• 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
• Application in the area of chest, heart or over the eyes
• Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
• Blood vessels and lymphatic vessels inflammation
• Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTL-785-7 Treatment	Device: BTL-785-7; Treatment with the BTL-785-7 applicator to the BTL-785F system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive Treatment Of Wrinkles	Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.	4 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: skin laxity; wrinkle
• Other Study ID Numbers: BTL-785_CTUS400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No