Efficacy Study for Magnetic Induction to Treat Wrinkles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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

Detailed Description

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Conditions

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Wrinkles and Rhytides

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Biofusionary Bebe

Intervention Type DEVICE

Eligibility Criteria

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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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerome Garden, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Laser and Dermatology Institute of Chicago

Locations

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Physicians Laser and Dermatolgy Institute of Chicago,LLC

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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0310-0017

Identifier Type: -

Identifier Source: org_study_id