A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing

The purpose of this research study is to evaluate the immediate effectiveness of the GFX™ device in reducing the furrows (deep frown lines) between eyebrows (glabellar region).

Study Overview

• Status: Completed
• Conditions: Forehead Wrinkles; Glabellar Furrowing
• Intervention / Treatment: Device: GFX System

Detailed Description

The purpose of this research study is to evaluate the acute ability of GFX to reduce glabellar furrowing.

Patients who have presented to the investigator for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Note: Class 1 or Higher)7 (Appendix N) are candidates for this study. All patients must consent to the procedure and agree to complete their post treatment evaluation visit.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Mateo, California, United States, 94401
      • Premier Plastic Surgery
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Speirs Clinic for Plastic Surgery
    • Englewood, Colorado, United States, 80113
      • Ben Lee, MD, LLC
    • Englewood, Colorado, United States, 80113
      • David M. Knize, MD
  • Florida
    • Tampa, Florida, United States, 33613
      • Jasin Facial Rejuvenation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has no medical contraindication
• Presenting for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Class 1 or Higher) are candidates for this study
• Is at least 18 years of age
• Signs a written informed consent
• Understands and accepts the obligation to present for the scheduled follow-up visit
• Understands that the GFX procedure may not be successful.

Exclusion Criteria:

• Has had an injection of botulinum toxin to the target area within the previous 3 months and still exhibits a positive cosmetic effect to the glabellar furrow
• Has had silicone, fat, collagen or a synthetic material placed in the glabellar region or surgical correction or excision of the glabellar furrows
• Has a known bleeding disorder
• Has received or is anticipated to receive anti-platelets, anti-coagulants thrombolytics or cancer therapy
• Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable)
• Has a history of chronic or recurrent infection or compromised immune system
• Has severe allergies manifested by a history of anaphylaxis
• Has known lidocaine hypersensitivity
• Is enrolled in another study
• Is Pregnant
• Has history of keloid formation
• The investigator believes the patient is not a suitable candidate for the GFX procedure, or is not likely to receive cosmetic benefit.

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: 1	Device: GFX System; The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.; Other Names: Radio Frequency Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful result from the GFX procedure acutely, without adverse effect	7 to 10 days post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimal or transient incidence of minor adverse events	7 to 10 days post procedure

Collaborators and Investigators

• Sponsor: Advanced Cosmetic Intervention
• Investigators: Study Director: James Newman, M.D., Director, Premier Plastic Surgery; Academic - Clinical Assistant Professor, Facial Plastic & Reconstructive Surgery and Otholaryngology - Head & Neck Surgery, Stanford University Medical center/Palo Alto VA

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Glabellar Furrowing
• Other Study ID Numbers: ACI 09-003