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.

Study Overview

• Status: Unknown
• Conditions: Wrinkles and Rhytides
• Intervention / Treatment: Device: Biofusionary Bebe

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Physicians Laser and Dermatolgy Institute of Chicago,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cosmesis	Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cosmesis	Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.	3 months

Collaborators and Investigators

• Sponsor: Rocky Mountain Biosystems, Inc.
• Investigators: Principal Investigator: Jerome Garden, MD, Physicians Laser and Dermatology Institute of Chicago

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): July 1, 2013
• Study Completion (ANTICIPATED): July 1, 2013

Study Registration Dates

• First Submitted: October 3, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (ESTIMATE): October 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 0310-0017