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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Cosmetic Intervention
ClinicalTrials.gov Identifier:
NCT00611273
First received: January 28, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Glabellar Furrowing
Device: GFX
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

Further study details as provided by Advanced Cosmetic Intervention:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimal or transient incidence of minor unanticipated adverse events. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: RF Nerve Ablation Device

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611273

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

No publications provided

Responsible Party: Advanced Cosmetic Intervention
ClinicalTrials.gov Identifier: NCT00611273     History of Changes
Other Study ID Numbers: ACI 007-02, WIRB 20062119
Study First Received: January 28, 2008
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Advanced Cosmetic Intervention:
Glabellar Furrowing

ClinicalTrials.gov processed this record on August 18, 2014