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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014