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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

January 7, 2011
February 8, 2012
December 2010
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01273961 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Laxity of Skin
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2012
August 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01273961
0310-0003
No
Rocky Mountain Biosystems, Inc.
Rocky Mountain Biosystems, Inc.
Not Provided
Principal Investigator: Andrew Wolfe, MD Center for Cosmetic Surgery
Study Director: Stephen Flock, PhD Rocky Mountain Biosystems, Inc.
Rocky Mountain Biosystems, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP