Start of Active Treatment Phase with Baseline Visit: If the Subject is determined to be eligible for the study, he/she will return to the clinic for the Baseline Visit. At this visit inclusion/exclusion criteria will be confirmed, patient will be enrolled in the study, randomization of the plaques will occur and baseline assessments will be performed including TPA. The test product will be dispensed, the user will be trained on how to use the product and the first treatment will be applied.