Abstract
BackgroundHemorrhoids are a common disorder that affects the quality of life of millions of people worldwide. The effectiveness of OTC medication is limited and they mainly provide symptomatic relief. In order to treat this ailment, we formulated PP110 Gel and Wipes, as a novel treatment for hemorrhoids. PP110 is based on known active ingredients with a topical film-forming agent designed to provide physical protection and prolonged tissue contact with the active ingredients.MethodsPP110 Gel, PP110 Wipes and the comparator Preparation-H® were used on three patient cohorts. Treatment was administered once daily for PP110, and three-four times daily for Preparation-H®, for 14 days. Six different clinical parameters relating to common symptoms of hemorrhoids were monitored.ResultsPP110 Gel was significantly better than Preparation-H® in reducing bleeding (Δ = 6 %), providing pain relief (Δ = 10 %) and controlling itching (Δ = 11 %). These three parameters are considered as the most common distressing symptoms for hemorrhoids patients, demonstrating that PP110 is superior to conventional treatment.ConclusionThis study demonstrated the efficacy of the PP110 Gel in treating hemorrhoids and its superiority to conventional treatments. The PP110 film-based formulation provides a slow-release mechanism and as a consequence, a prolonged therapeutic window. PP110 was both more effective in reducing hemorrhoids symptoms and more convenient to use, in that it only required application once per day.
Highlights
Hemorrhoids are a common disorder that affects the quality of life of millions of people worldwide
One of the major challenges with current treatments is the demanding treatment regimen, which requires application several times a day. To overcome this problem and to improve patient compliance we devised PP110 Gel and PP110 Wipes, two novel formulations that were designed with a film-forming agent, for the treatment of grade 2–3 hemorrhoids (Grade 2: hemorrhoids which prolapse upon bearing down, but spontaneous reduction; Grade 3: hemorrhoids which prolapse upon bearing down requiring manual reduction)
Bleeding, which was the primary endpoint of this trial improved by more than 30 % within 1–2 days of treatment in all three arms (Fig. 2a), but was most notably affected by the PP110 Gel, which yielded a mean 45 % Area under the curve (AUC) across the treatment period
Summary
Hemorrhoids are a common disorder that affects the quality of life of millions of people worldwide. Most hemorrhoids symptoms are treated with over-thecounter (OTC) preparations [2], products that typically contain active analgesics, vasoconstrictors, corticosteroids, or lubricants and provide temporary symptomatic relief. These products come in various forms including ointments, creams, gels, suppositories, and medicated wipes [9, 10]. One of the major challenges with current treatments is the demanding treatment regimen, which requires application several times a day To overcome this problem and to improve patient compliance we devised PP110 Gel and PP110 Wipes, two novel formulations that were designed with a film-forming agent, for the treatment of grade 2–3 hemorrhoids (Grade 2: hemorrhoids which prolapse upon bearing down, but spontaneous reduction; Grade 3: hemorrhoids which prolapse upon bearing down requiring manual reduction). The aim of this study is to assess the efficacy and safety of the product and to compare them to those of Preparation-H® cream in a prospective, randomized study
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