NCT00612378

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Advanced Cosmetic Intervention · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Glabellar Furrowing
• Forehead Wrinkles

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2008-02-11
• Last updated: 2014-06-24

Locations

5 sites across 1 country: United States