Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

Rocky Mountain Biosystems

Status

Completed

Conditions

Laxity of Skin

Treatments

Device: AuraLevée treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01273961

0310-0003

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 used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Enrollment

20 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female 21 to 70 years old,
For females, at least 9 months post-partum,
Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck 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),
Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
Suffering from hormonal imbalance which may affect weight or cellulite,
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 or breast feeding,
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.