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

Forehead Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612378
• Other study ID #: ACI 09-003
• Status: Completed
• Phase: N/A
• First received: January 18, 2008
• Last updated: June 23, 2014
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: June 2014
• Source: Advanced Cosmetic Intervention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Forehead Wrinkles
• Glabellar Furrowing

Intervention

Device:
• GFX System
The GFX system employs minimally invasive technique utilizing bi-polar radio frequency (RF) technology. GFX ablates nerves activating the muscles that cause glabellar furrowing.

Locations

Country	Name	City	State
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	Premier Plastic Surgery	San Mateo	California
United States	Jasin Facial Rejuvenation	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Cosmetic Intervention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful result from the GFX procedure acutely, without adverse effect		7 to 10 days post procedure	No
Secondary	Minimal or transient incidence of minor adverse events		7 to 10 days post procedure	Yes