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Sponsored by: |
Advanced Cosmetic Intervention |
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Information provided by: | Advanced Cosmetic Intervention |
ClinicalTrials.gov Identifier: | NCT00612378 |
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 |
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Glabellar Furrowing Forehead Wrinkles |
Device: GFX System |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Multi-Center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing |
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 |
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1: Experimental |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Responsible Party: | ACI ( Charles W. Coates ) |
Study ID Numbers: | ACI 09-003 |
Study First Received: | January 18, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00612378 |
Health Authority: | United States: Institutional Review Board |
Glabellar Furrowing |