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.

Study Overview

• Status: Completed
• Conditions: Laxity of Skin
• Intervention / Treatment: Device: Auralevée device

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • Laser Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved cosmesis	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.	2-6 timepoints from 4 days to 6 months

Collaborators and Investigators

• Sponsor: Rocky Mountain Biosystems, Inc.
• Investigators: Principal Investigator: Peter Cooperrider, MD, Laser Treatment Center; Study Director: Stephen Flock, PhD, Rocky Mountain Biosystems, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 0310-0002A