Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Prospective, single centre, evaluator-blind study of the safety and performance of fractional
 radiofrequency (RF) for the treatment and reduction of facial wrinkles.
The study will evaluate 15 subjects requesting treatment of their facial wrinkles. The study
 will involve three treatments on both sides of the face with 3-5 week intervals between each
 treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis
 will be performed on all subjects who receive at least one treatment. An additional
 histological analysis will be conducted including up to 12 of the participating subjects.
Inclusion Criteria:

 1. Healthy, male or female subjects over 21 years of age who are seeking treatment and
 reduction of their facial wrinkles.

 2. Able to read, understand and voluntarily provide written Informed Consent.

 3. Able and willing to comply with the treatment/follow-up schedule and requirements.

 4. Women of child-bearing age are required to be using a reliable method of birth control
 at least 3 months prior to study enrollment and for the duration of the study and have
 a negative Urine Pregnancy test at baseline.

 Exclusion Criteria:

 1. Implantable defibrillators, cardiac pacemakers, and other metal implants

 2. Subjects with any implantable metal device in the treatment area

 3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere
 in the body (e.g. cochlear implant).

 4. Permanent implant in the treated area, such as metal plates and screws, or an injected
 chemical substance.

 5. Current or history of any kind of cancer, or pre-malignant moles.

 6. Severe concurrent conditions, such as cardiac disorders.

 7. Pregnancy or intending to become pregnant during the study and nursing.

 8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use
 of immunosuppressive medications.

 9. History of diseases stimulated by heat, such as recurrent herpes simplex in the
 treatment area; may be enrolled only after a prophylactic regime has been followed for
 2 weeks or longer prior to enrollment, or according to Investigator's discretion.

 10. Poorly controlled endocrine disorders, such as diabetes.

 11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and
 rash.

 12. History of skin disorders, such as keloids, abnormal wound healing, as well as very
 dry and fragile skin.

 13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily
 aspirin).

 14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last
 three months, if face is treated.

 15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or
 topical retinoids within three months prior to treatment; or as per physician's
 discretion.

 16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing
 agents) one week before and after each treatment session.

 17. Any surgical procedure in the treatment area within the last six months or before
 complete healing.

 18. Treating over tattoo or permanent makeup.

 19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two
 weeks.

 20. As per the practitioner's discretion, refrain from treating any condition which might
 make it unsafe for the patient.