Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment

Exclusion Criteria

• •1. Pacemaker or internal defibrillator.
• •2. Permanent implant in the treated area, such as metal plates and screws or silicon, unless deep enough in the bone.
• •3. Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat injections or other augmentation methods with bio-material during last 6 months.
• •4. Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
• •5. Current severe medical conditions, such as heart and lung disorders.
• •6. Pregnant or breastfeeding.
• •7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• •8. History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores) in the treatment area, unless treated by following a preventive regime.
• •9. Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.
• •10. Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea.
• •11. History of skin disorders, keloids (excessive scarring), abnormal wound healing, as well as very dry and fragile skin.
• •12. History of bleeding disorders, or use of anticoagulants in the last 10 days.
• •13. Any facial surgery performed within 12 months prior to treatment.
• •14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
• •15. Received treatment with light, laser, radiofrequency (RF), or other devices in the treated area within 6 months.
• •16. Used isotretinoin (Accutane®) within 6 months prior to treatment.
• •17. Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) 1 week before and after each treatment session.
• •18. Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
• •19. Subjects that have been on a steroid regimen within the past 3 months.