Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

Overview

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Full Title of Study: “Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2011

Interventions

  • Device: Auralevée device
    • Single treatment with Auralevée device.

Clinical Trial Outcome Measures

Primary Measures

  • Improved cosmesis
    • Time Frame: 2-6 timepoints from 4 days to 6 months
    • Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female at least 21 years old,
  • Apparently healthy,
  • Informed consent signed by the subject.

Exclusion Criteria

  • Tobacco smokers,
  • History of skin hypersensitivity,
  • Current skin disorder or infection (e.g., herpes simplex),
  • Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
  • Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
  • Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
  • The current or recent use (within the past 12 months) of isotretinoin,
  • Pregnancy or breast feeding,
  • Insulin dependent diabetic subjects,
  • Oxygen dependent subjects,
  • Subjects with severe chronic illness, scleroderma, or lupus,
  • Subjects with open sores or scars in the treatment region, or
  • Subjects with ischemia in the treatment region.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rocky Mountain Biosystems, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Cooperrider, MD, Principal Investigator, Laser Treatment Center
    • Stephen Flock, PhD, Study Director, Rocky Mountain Biosystems, Inc.

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