Status:
COMPLETED
A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
Lead Sponsor:
Advanced Cosmetic Intervention
Conditions:
Glabellar Furrowing
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing
Detailed Description
A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00611273
Start Date
September 1 2007
End Date
April 1 2008
Last Update
June 24 2014
Active Locations (10)
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1
Paul S. Nassif, MD, FACS
Beverly Hills, California, United States, 90212
2
James Newman
San Mateo, California, United States, 94401
3
Michael E. Jansin, MD
Tampa, Florida, United States, 33613
4
Foad Nahai, M.D., F.A.C.S.
Atlanta, Georgia, United States, 30327