Status:
COMPLETED
A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
Lead Sponsor:
Advanced Cosmetic Intervention
Conditions:
Glabellar Furrowing
Forehead Wrinkles
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 class...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00612378
Start Date
September 1 2007
End Date
March 1 2008
Last Update
June 24 2014
Active Locations (5)
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1
Premier Plastic Surgery
San Mateo, California, United States, 94401
2
Speirs Clinic for Plastic Surgery
Colorado Springs, Colorado, United States, 80904
3
Ben Lee, MD, LLC
Englewood, Colorado, United States, 80113
4
David M. Knize, MD
Englewood, Colorado, United States, 80113