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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Advanced Cosmetic Intervention
ClinicalTrials.gov Identifier:
NCT00612378
First received: January 18, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Glabellar Furrowing
Forehead Wrinkles
Device: GFX System

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 Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing

Further study details as provided by Advanced Cosmetic Intervention:

Primary Outcome Measures:
  • Successful result from the GFX procedure acutely, without adverse effect [ Time Frame: 7 to 10 days post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimal or transient incidence of minor adverse events [ Time Frame: 7 to 10 days post procedure ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Radio Frequency Ablation

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.

  Eligibility

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

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.
  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: NCT00612378

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

No publications provided

Responsible Party: Advanced Cosmetic Intervention
ClinicalTrials.gov Identifier: NCT00612378     History of Changes
Other Study ID Numbers: ACI 09-003
Study First Received: January 18, 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 July 22, 2014