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Efficacy Study for Magnetic Induction to Treat Wrinkles

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier:
NCT01701440
First received: October 3, 2012
Last updated: October 10, 2012
Last verified: October 2012
History of Changes

October 3, 2012
October 10, 2012
October 2012
July 2013   (final data collection date for primary outcome measure)
Improvement in cosmesis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared
Same as current
Complete list of historical versions of study NCT01701440 on ClinicalTrials.gov Archive Site
Improvement in cosmesis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.
Same as current
Not Provided
Not Provided
 
Efficacy Study for Magnetic Induction to Treat Wrinkles
Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides

In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wrinkles and Rhytides
Device: Biofusionary Bebe
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2013
July 2013   (final data collection date for primary outcome measure)

The inclusion criteria for the study are:

  • Male or female 21 to 65 years old,
  • Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms & buttocks 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:

The exclusion criteria for the study are:

  • History of skin hypersensitivity,
  • Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area,
  • 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,
  • 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 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01701440
0310-0017
No
Rocky Mountain Biosystems, Inc.
Rocky Mountain Biosystems, Inc.
Not Provided
Principal Investigator: Jerome Garden, MD Physicians Laser and Dermatology Institute of Chicago
Rocky Mountain Biosystems, Inc.
October 2012

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