BTL-785F Device for Non-invasive Facial Rejuvenation in Patients Injected With Botulinum Toxin

NCT05524766 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS1100
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical safety and the efficacy of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial treatment in patients injected with botulinum toxin. The aim is to investigate the improvement of overall facial appearance and muscle tone.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Facial Appearance Change

  Three evaluators will evaluate facial appearance according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.

  5 months

Secondary Outcomes (3)

• Facial expression assessment

  5 months

• Therapy Comfort

  5 months

• Subject Satisfaction

  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 improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

Device: BTL-785-7 Treatment

Control

NO INTERVENTION

Two (2) patients will be enrolled in the control group study and will not receive any treatment. Following the completion of the investigation, the control group patients will be offered the same treatment course as the active group.

Interventions

BTL-785-7 Treatment DEVICE

Treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

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 injected with type A botulinum toxin for facial wrinkles improvement in the past month, but no sooner than 1 week
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• 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 (1)

Refresh Dermatology

Houston, Texas, 77081, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: July 6, 2022
• Primary Completion: December 9, 2022
• Study Completion: February 8, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)