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

Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring

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.

Study Overview

• Status: Completed
• Conditions: Laxity of Skin
• Intervention / Treatment: Device: AuraLevée treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cosmesis	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.	1 and 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 9, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 0310-0003