Clinical trial NCT00612378: A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
Official title: A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glabellar Furrowing
Forehead Wrinkles
Keywords: Glabellar Furrowing
Lead sponsor: Advanced Cosmetic Intervention
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Successful result from the GFX procedure acutely, without adverse effect
timeFrame: 7 to 10 days post procedure
Secondary outcomes:
measure: Minimal or transient incidence of minor adverse events
timeFrame: 7 to 10 days post procedure
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Premier Plastic Surgery
state: California
city: Colorado Springs
country: United States
facility: Speirs Clinic for Plastic Surgery
state: Colorado
city: Englewood
country: United States
facility: Ben Lee, MD, LLC
state: Colorado
city: Englewood
country: United States
facility: David M. Knize, MD
state: Colorado
city: Tampa
country: United States
facility: Jasin Facial Rejuvenation
state: Florida
Study officials:
affiliation: Director, Premier Plastic Surgery; Academic - Clinical Assistant Professor, Facial Plastic & Reconstructive Surgery and Otholaryngology - Head & Neck Surgery, Stanford University Medical center/Palo Alto VA
name: James Newman, M.D.
role: STUDY_DIRECTOR
References: