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

Completed · Not applicable

Conditions studied: Glabellar Furrowing, Forehead Wrinkles

In brief

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).

Key facts

Study ID

NCT00612378

Run by

Advanced Cosmetic Intervention

People needed

94

Starts

2007-09-01

Expected to finish

2008-03-01

Last updated by the study team

2014-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Premier Plastic Surgery — San Mateo, California, United States
• Speirs Clinic for Plastic Surgery — Colorado Springs, Colorado, United States
• Ben Lee, MD, LLC — Englewood, Colorado, United States
• David M. Knize, MD — Englewood, Colorado, United States
• Jasin Facial Rejuvenation — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.