BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement

NCT05524779 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS1300
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Noninvasive Treatment Of Wrinkles

  Assess change in wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant decrease of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.

  5 months

Secondary Outcomes (3)

• Skin Quality Assessment

  5 months

• Therapy Comfort

  5 months

• Subject Satisfaction

  5 months

Study Arms (1)

BTL-785-7 Treatment

EXPERIMENTAL

Treatment of wrinkles with the BTL-785-7 applicator to the BTL-785F system.

Device: BTL-785-7

Interventions

BTL-785-7 DEVICE

Treatment with the BTL-785-7 applicator to the BTL-785F system.

BTL-785-7 Treatment

Eligibility Criteria

• Age: 21 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, 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)
• Pregnancy/nursing or IVF procedure

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (5)

Contour Medical

Gilbert, Arizona, 85297, United States

Location

Holden Timeless Beauty

San Marcos, California, 92069, United States

Location

Precision Skin Institute

Davie, Florida, 33328, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Jennifer Levine MD

New York, New York, 10075, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: October 19, 2022
• Primary Completion: April 20, 2023
• Study Completion: June 25, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)