Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

Rocky Mountain Biosystems

Status

Completed

Conditions

Laxity of Skin

Treatments

Device: Auralevée device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01279226

0310-0002A

Details and patient eligibility

About

The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Enrollment

40 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female at least 21 years old,
Apparently healthy,
Informed consent signed by the subject.

Exclusion criteria

Tobacco smokers,
History of skin hypersensitivity,
Current skin disorder or infection (e.g., herpes simplex),
Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
Subjects with a 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 or breast feeding,
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.