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

Inclusion Criteria:

1. Presence of mild to moderate acne.
2. Skin Type I to VI (Fitzpatrick).
3. Males or females who are 21-65 years old.
4. Willingness to follow the treatment schedule, post-treatment care and have photographs taken.

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.