Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rocky Mountain Biosystems, Inc.

ClinicalTrials.gov Identifier:

NCT01273961

First received: January 7, 2011

Last updated: February 8, 2012

Last verified: February 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 used to treat and 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 treatment

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics

U.S. FDA Resources

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

Primary Outcome Measures:

Improvement in cosmesis [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.

Enrollment:	20
Study Start Date:	December 2010
Study Completion Date:	January 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female 21 to 70 years old,
For females, at least 9 months post-partum,
Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
Apparently healthy,
Informed consent signed by the subject.

Exclusion Criteria:

History of skin hypersensitivity,
Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
Suffering from hormonal imbalance which may affect weight or cellulite,
Subjects with 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,
Infectious diseases (such as HIV) present,
Are a tobacco smoker,
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: NCT01273961

Locations

United States, Colorado
Center for Cosmetic Surgery
Golden, Colorado, United States, 80401

Sponsors and Collaborators

Rocky Mountain Biosystems, Inc.

Investigators

Principal Investigator:	Andrew Wolfe, MD	Center for Cosmetic Surgery
Study Director:	Stephen Flock, PhD	Rocky Mountain Biosystems, Inc.

More Information

No publications provided

Responsible Party:	Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier:	NCT01273961 History of Changes
Other Study ID Numbers:	0310-0003
Study First Received:	January 7, 2011
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013

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