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

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: NCT01273961
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : February 9, 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 used to treat and 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 treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
Study Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

Intervention Details:
    Device: AuraLevée treatment
    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.

Primary Outcome Measures :
  1. Improvement in cosmesis [ Time Frame: 1 and 3 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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): NCT01273961

United States, Colorado
Center for Cosmetic Surgery
Golden, Colorado, United States, 80401
Sponsors and Collaborators
Rocky Mountain Biosystems, Inc.
Principal Investigator: Andrew Wolfe, MD Center for Cosmetic Surgery
Study Director: Stephen Flock, PhD Rocky Mountain Biosystems, Inc.

Responsible Party: Rocky Mountain Biosystems, Inc. Identifier: NCT01273961     History of Changes
Other Study ID Numbers: 0310-0003
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012