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
  Purpose

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


Condition Intervention
Wrinkles and Rhytides
Device: Biofusionary Bebe

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Rocky Mountain Biosystems, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701440

Locations
United States, Illinois
Physicians Laser and Dermatolgy Institute of Chicago,LLC
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rocky Mountain Biosystems, Inc.
Investigators
Principal Investigator: Jerome Garden, MD Physicians Laser and Dermatology Institute of Chicago
  More Information

No publications provided

Responsible Party: Rocky Mountain Biosystems, Inc.
ClinicalTrials.gov Identifier: NCT01701440     History of Changes
Other Study ID Numbers: 0310-0017
Study First Received: October 3, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014