Efficacy Study for Magnetic Induction to Treat Wrinkles

NCT ID: NCT01701440

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

Brief Summary

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

Conditions

Wrinkles and Rhytides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Biofusionary Bebe

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rocky Mountain Biosystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome Garden, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Laser and Dermatology Institute of Chicago

Locations

Physicians Laser and Dermatolgy Institute of Chicago,LLC

Chicago, Illinois, United States

Countries

United States

Other Identifiers

0310-0017

Identifier Type: -

Identifier Source: org_study_id