BTL-785F Device for Non-invasive Treatment of Wrinkles and Improvement of the Face Appearance

NCT05524805 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS800
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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 changes in 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

Secondary Outcomes (3)

• Evaluation of skin quality and aesthetic changes of the treated areas after the therapies

  4 months

• Subject Satisfaction

  4 months

• Therapy Comfort

  4 months

Study Arms (1)

BTL-785-7 Treatment

EXPERIMENTAL

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

Device: BTL-785-7 Treatment

Interventions

BTL-785-7 Treatment DEVICE

Treatment of wrinkles 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 (2)

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

Location

Skin and Allergy Center

Spring Hill, Tennessee, 37174, 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: June 28, 2022
• Primary Completion: May 15, 2023
• Study Completion: April 9, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)