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Efficacy Study for Magnetic Induction to Treat Wrinkles

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ClinicalTrials.gov Identifier: NCT01701440
Recruitment Status : Unknown
Verified October 2012 by Rocky Mountain Biosystems, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Rocky Mountain Biosystems, Inc.

Study Description
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Brief Summary:
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.

Condition or disease Intervention/treatment Phase
Wrinkles and Rhytides Device: Biofusionary Bebe Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides
Study Start Date : October 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Improvement in cosmesis [ Time Frame: 1 month ]
    Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared


Secondary Outcome Measures :
  1. Improvement in cosmesis [ Time Frame: 3 months ]
    Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01701440


Locations
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United States, Illinois
Physicians Laser and Dermatolgy Institute of Chicago,LLC
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rocky Mountain Biosystems, Inc.
Investigators
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Principal Investigator: Jerome Garden, MD Physicians Laser and Dermatology Institute of Chicago
More Information
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Responsible Party: Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT01701440    
Other Study ID Numbers: 0310-0017
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012