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

History of Changes

Purpose

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	Intervention
Laxity of Skin	Device: Auralevée device

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Further study details as provided by Rocky Mountain Biosystems, Inc.:

Primary Outcome Measures:

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.

Enrollment:	40
Study Start Date:	February 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Single treatment with Auralevée device.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279226

Locations

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

Sponsors and Collaborators

Rocky Mountain Biosystems, Inc.

Investigators

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

More Information

No publications provided

Responsible Party:	Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier:	NCT01279226 History of Changes
Other Study ID Numbers:	0310-0002A
Study First Received:	January 14, 2011
Last Updated:	November 30, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013

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