Efficacy Study for Magnetic Induction to Treat Wrinkles

Rocky Mountain Biosystems

Status

Unknown

Conditions

Wrinkles and Rhytides

Treatments

Device: Biofusionary Bebe

Study type

Interventional

Funder types

Industry

Identifiers

0310-0017

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.