A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3

A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3

Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream). Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region. At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage. Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.

Inclusion Criteria: Age 18-70 Bleeding hemorrhoids with / without pain Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids Signed Informed Consent Exclusion Criteria: Known rectal sensitivity Rectal infection Grade IV hemorrhoids Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment Known inflammatory bowel disease Anal fissure Military personnel Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing Patients who have been involved in another experimental trial within the past 30 days Patients presently diagnosed with cancer