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

Glabellar Furrowing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611273
• Other study ID #: ACI 007-02
• Secondary ID: WIRB 20062119
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2008
• Last updated: June 23, 2014
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: June 2014
• Source: Advanced Cosmetic Intervention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Furrowing

Intervention

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.

Locations

Country	Name	City	State
Canada	David A. Ellis, MD	Toronto	Ontario
United States	Foad Nahai, M.D., F.A.C.S.	Atlanta	Georgia
United States	Paul S. Nassif, MD, FACS	Beverly Hills	California
United States	J. Smythe Rich, III, M.D	Columbia	South Carolina
United States	Steven P. Block, MD	Highland Park	Illinois
United States	Russell W. Kridel, MD	Houston	Texas
United States	Roger C. Mixter, MD	Milwaukee	Wisconsin
United States	James Newman	San Mateo	California
United States	Keith LaFerriere, MD	Springfield	Missouri
United States	Michael E. Jansin, MD	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Cosmetic Intervention

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Minimal or transient incidence of minor unanticipated adverse events.		30 days	No