Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne

Inclusion Criteria:

• Subject is >16 years of age

• General good health confirmed by medical history and examination of the treatedarea.

• Subjects with mild to severe Acne Vulgaris, defined as a baseline IGA (Investigator's Global Assessment) score of 2, 3 or 4 and 10-100 inflammatorylesions (papules or pustules).

• The patients should be willing to comply with the study procedure and schedule,including the follow up visits, and will refrain from using any other acne treatmentmethods during the entire study period.

• Willing to avoid sun/UV exposure for duration of the study unless using sunscreen.

• Willing to refrain from starting or changing hormonal contraception for duration ofstudy.

• Subject understands and is willing to sign the informed consent to participate inthe study. Parental (or other) guardians must provide consent for minors under theage of 18.

Exclusion Criteria:- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.

• Patients who are under pharmacological anti-acne therapy (isotretinoin orantibiotics) for the last 6 months.

• Use of botulinum toxin within prior 1 month.

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

• Current or history of cancer, or premalignant condition in the treatment area.

• Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolledhypertension, and liver or kidney diseases.

• Subject who are pregnant or nursing.

• Started or changed hormonal contraceptive within prior month of study.

• Subject is unwilling or unlikely to refrain from high UV exposure to face.

• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, oruse of immunosuppressive medications.

• Patients with history of diseases stimulated by heat, such as recurrent HerpesSimplex in the treatment area

• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.

• Any active condition in the treatment area, such as sores, psoriasis, eczema, andrash.

• History of skin disorders, keloids, abnormal wound healing, as well as very dry andfragile skin.

• History of bleeding coagulopathies or use of anticoagulants in the last 10 days.

• Any surgery in treated area within 3 months prior to treatment.

• Subject received other treatments such as light, CO2 laser or RF in the treatmentarea within 6 months of study start date.

• Simultaneous participation in another investigator drug or device study orcompletion of the follow-up phase for the primary endpoint of any previous studyless than 30 days prior to the first evaluation in this study.

• Subject that has any condition that, at the investigator's discretion, renders thesubject unsuitable for participation in this clinical research study.