Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279226
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):
Rocky Mountain Biosystems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Laxity of Skin Device: Auralevée device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
Study Start Date : February 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01279226

United States, Washington
Laser Treatment Center
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Rocky Mountain Biosystems, Inc.
Principal Investigator: Peter Cooperrider, MD Laser Treatment Center
Study Director: Stephen Flock, PhD Rocky Mountain Biosystems, Inc.

Responsible Party: Rocky Mountain Biosystems, Inc. Identifier: NCT01279226     History of Changes
Other Study ID Numbers: 0310-0002A
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: October 2012