Efficacy Study for Magnetic Induction to Treat Wrinkles

Not Applicable

• Conditions: Wrinkles and Rhytides

• Registration Number: NCT01701440
• Lead Sponsor: Rocky Mountain Biosystems, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-10
• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in cosmesis	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

Name	Time	Method
Improvement in cosmesis	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.

Trial Locations

Locations (1)

Physicians Laser and Dermatolgy Institute of Chicago,LLC; 🇺🇸 Chicago, Illinois, United States