NCT00611273

Brief Summary

Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

January 28, 2008

Last Update Submit

June 23, 2014

Conditions

Glabellar Furrowing

Keywords

Glabellar Furrowing

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (1)

  • Minimal or transient incidence of minor unanticipated adverse events.

    30 days

Study Arms (1)

1

EXPERIMENTAL

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 R) are candidates for this study.

Device: GFX

Interventions

GFXDEVICE

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

Also known as: RF Nerve Ablation Device
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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

You may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Paul S. Nassif, MD, FACS

Beverly Hills, California, 90212, United States

Location

James Newman

San Mateo, California, 94401, United States

Location

Michael E. Jansin, MD

Tampa, Florida, 33613, United States

Location

Foad Nahai, M.D., F.A.C.S.

Atlanta, Georgia, 30327, United States

Location

Steven P. Block, MD

Highland Park, Illinois, 60035, United States

Location

Keith LaFerriere, MD

Springfield, Missouri, 65807, United States

Location

J. Smythe Rich, III, M.D

Columbia, South Carolina, 29203, United States

Location

Russell W. Kridel, MD

Houston, Texas, 77030, United States

Location

Roger C. Mixter, MD

Milwaukee, Wisconsin, 53217, United States

Location

David A. Ellis, MD

Toronto, Ontario, M2N 1M9, Canada

Location

Study Officials

  • James Newman, MD

    Premier Plastic Surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

September 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

CA(1)US(9)