Clinical trial NCT00611273: A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
Official title: A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Furrowing
Keywords: Glabellar Furrowing
Lead sponsor: Advanced Cosmetic Intervention
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 260
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: 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 Criteria: 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 Criteria: 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

Primary outcomes:
measure: Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.
timeFrame: 18 months
Secondary outcomes:
measure: Minimal or transient incidence of minor unanticipated adverse events.
timeFrame: 30 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Paul S. Nassif, MD, FACS
state: California
city: San Mateo
country: United States
facility: James Newman
state: California
city: Tampa
country: United States
facility: Michael E. Jansin, MD
state: Florida
city: Atlanta
country: United States
facility: Foad Nahai, M.D., F.A.C.S.
state: Georgia
city: Highland Park
country: United States
facility: Steven P. Block, MD
state: Illinois
city: Springfield
country: United States
facility: Keith LaFerriere, MD
state: Missouri
city: Columbia
country: United States
facility: J. Smythe Rich, III, M.D
state: South Carolina
city: Houston
country: United States
facility: Russell W. Kridel, MD
state: Texas
city: Milwaukee
country: United States
facility: Roger C. Mixter, MD
state: Wisconsin
city: Toronto
country: Canada
facility: David A. Ellis, MD
state: Ontario
Study officials:
affiliation: Premier Plastic Surgery
name: James Newman, MD
role: STUDY_DIRECTOR
References: