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

January 28, 2008
June 23, 2014
September 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00611273 on ClinicalTrials.gov Archive Site
Minimal or transient incidence of minor unanticipated adverse events. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
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

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glabellar Furrowing
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
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.
Intervention: Device: GFX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00611273
ACI 007-02, WIRB 20062119
No
Advanced Cosmetic Intervention
Advanced Cosmetic Intervention
Not Provided
Study Director: James Newman, MD Premier Plastic Surgery
Advanced Cosmetic Intervention
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP