A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing

Study Overview

• Status: Completed
• Conditions: Glabellar Furrowing
• Intervention / Treatment: Device: GFX

Detailed Description

A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2N 1M9
      • David A. Ellis, MD
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Paul S. Nassif, MD, FACS
    • San Mateo, California, United States, 94401
      • James Newman
  • Florida
    • Tampa, Florida, United States, 33613
      • Michael E. Jansin, MD
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Foad Nahai, M.D., F.A.C.S.
  • Illinois
    • Highland Park, Illinois, United States, 60035
      • Steven P. Block, MD
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Keith LaFerriere, MD
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • J. Smythe Rich, III, M.D
  • Texas
    • Houston, Texas, United States, 77030
      • Russell W. Kridel, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53217
      • Roger C. Mixter, MD

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: The patient will be included if:

• Has no medical contraindication
• Presents 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)
• Is at least 18 years of age
• Signs a written informed consent
• Understands and accepts the obligation to present for scheduled follow-up visits
• Understands that the GFX procedure may not be successful
• Presents at the one month follow-up visit with an improvement from the base line RNKLS score

Exclusion Criteria: The patient will be excluded if:

• Has had an injection of botulinum toxin to the target area within the previous 4 months and still exhibits a positive cosmetic effect to the glabellar frown.
• 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
• Pregnant
• 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
• 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 benefitPresents at the one month follow-up visit with no improvement from the base line RNKLS score

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; 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 R) are candidates for this study.	Device: GFX; 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: RF Nerve Ablation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimal or transient incidence of minor unanticipated adverse events.	30 days

Collaborators and Investigators

• Sponsor: Advanced Cosmetic Intervention
• Investigators: Study Director: James Newman, MD, Premier Plastic Surgery

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 8, 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 007-02; WIRB 20062119