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Completed

NCT Number: NCT00611273

A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing

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

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Key information

Conditions

Glabellar Furrowing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

David A. Ellis, MD, Toronto, Ontario, Canada

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About this study

A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GFX

Device

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

Other names: RF Nerve Ablation Device

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.

    Time frame: 18 months

Secondary outcomes

  1. Minimal or transient incidence of minor unanticipated adverse events.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Advanced Cosmetic Intervention

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 8, 2008
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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