Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face

NCT05524662 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS900
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Histological examination

  Evaluation of the facial skin to assess the changes related to connective tissue structural proteins in the biopsies obtained from the treatment group and control. Subjects will have one 3 mm punch biopsy obtained at the baseline and subsequent biopsies at the follow-up visits.

  5 months

Secondary Outcomes (4)

• Subject Satisfaction

  5 months

• Therapy Comfort

  5 months

• Evaluation of Wrinkle Severity

  5 months

• Evaluation of Overall Facial Appearance According to GAIS

  5 months

Study Arms (2)

BTL-785-7 Treatment

EXPERIMENTAL

Subjects will be enrolled for an active treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.

Device: BTL-785-7

Control

NO INTERVENTION

One subject will serve as a control.

Interventions

BTL-785-7 DEVICE

Treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.

BTL-785-7 Treatment

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Schweiger Dermatology PC, Reseach Division

Hackensack, New Jersey, 07601, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: June 15, 2022
• Primary Completion: December 10, 2022
• Study Completion: March 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)