Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier:
NCT01279226
First received: January 14, 2011
Last updated: November 30, 2012
Last verified: October 2012

January 14, 2011
November 30, 2012
February 2010
February 2011   (final data collection date for primary outcome measure)
Improved cosmesis [ Time Frame: 2-6 timepoints from 4 days to 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01279226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides
Radiofrequency Magnetic Induction Device for Use in Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Laxity of Skin
Device: Auralevée device
Single treatment with Auralevée device.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01279226
0310-0002A
Yes
Rocky Mountain Biosystems, Inc.
Rocky Mountain Biosystems, Inc.
Not Provided
Principal Investigator: Peter Cooperrider, MD Laser Treatment Center
Study Director: Stephen Flock, PhD Rocky Mountain Biosystems, Inc.
Rocky Mountain Biosystems, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP