Objective: External hemorrhoids are enlarged, bulging blood vessels in and around the anus and lower rectum. They associate several pathologies such as engorged, edematous and inflamed sinusoids, with numerous proinflammatory cytokines on their surface, requiring a multi-target therapeutic approach. In the absence of any effective treatment, we assessed a newly conceived osmotically active, hypertonic, filmogen solution (Pileseptine-e) directed at attracting hypotonic liquid and helping suppress inflammation. The clinical efficacy and safety of Pileseptine-e on external hemorrhoids was evaluated in this study. Methods: A 2-week treatment + 1-week follow-up, comparative, randomized, double blind, clinical trial with Pileseptine-e (n=37, test product) versus saline spray (n=17, placebo) was performed in patients suffering from external hemorrhoids. Test and placebo products were applied as 3-4 sprays, 3-4 times per day, for 14 consecutive days. Parameters were evaluated employing a 0-4 or 0-10 scoring scale, before treatment (baseline, T0), 2h after 1st treatment, and on Days 2, 3, 8, and 14, with follow-up check on Day 21. Results: The test product induced an instant and strong outward exudation of liquid from inside the edematous hemorrhoids, thereby cleaning their surface, keeping it hydrated, and reducing pain and itching. A strong reduction in the size of hemorrhoids and rectal bleeding was also observed, which improved the quality of life of the patients considerably. The placebo product also provided noticeable symptomatic relief, but without effect on the size of hemorrhoids. No adverse effects were observed in any patient. Conclusion: Reducing edema to allow hemorrhoidal volume to regress, and to normalize the structural physiology of the anal area, is the primary prerequisite to treat external hemorrhoids. Pileseptine-e is an antiedematous, cleaning, hydrating, safe and non-irritant filmogen solution that represents great advancement in the treatment of external hemorrhoids.

Objective: Allergic rhinitis (AR) is oversensitivity of nasal mucosa to allergen exposure leading to IgE-mediated nasal mucosal inflammation and cellular destruction. Applying any chemical drug over the nasal mucosa may provide symptomatic relief but at the same time the presence of chemicals, such as cortisones and antihistaminic, hampers mucosa repair and, in consequence, cellular defense functions. Therefore, cleaning, avoiding allergen exposure, and protecting nasal mucosa from contact with allergens with a cell-friendly mechanical device, could be an effective remedy to treat allergic rhinitis. Methods:A double blind, randomized, placebo controlled, multicenter clinical trial was conducted in patients suffering from severe AR. 15 patients were treated with saline as comparator product (CP) versus 31 treated with the test product (TP). The test product contained a natural gum-glycerol solution (VB-Gy) which was rendered filmogen using inert natural polymers (Allercyanidin-H) and termed as VB-Gy-Allercyanidin-H formula. The products (15 ml sprays) were applied topically over the nasal mucosa, 3-4 times a day over a period of 3 weeks. Total, reflective and instantaneous nasal symptom scores for rhinorrhea, nasal discharge, sneezing, and itching, as well as ocular scores (itching, tearing, redness) and rescue medicine use scores were evaluated daily during weeks -1 to +3 employing a 0 (no symptoms) to 3 (severe symptoms) scoring scale. Rhino-conjunctivitis quality of life (RQLQ) questionnaires were completed at the start and at the end of the study. Saline solution (CP) was used identically to the TP. Mean weekly results in CP and TP groups were compared with the scores at the start of treatment (baseline) and between the two groups.Results: CP was found to reduce only slightly the symptomatic manifestation of allergic rhinitis. The mean reduction compared to baseline at the end of weeks 1, 2, and 3 was respectively 11.7%, 13.6% and 15.1% for total nasal symptom scores (rTNSS); 9.9%, 14.5%, and 15.8% for total ocular symptom scores (rTOSS); and 4.97%, 8.45%, and 10.94% for pre-dose instantaneous total ocular symptom scores (am-iTOSS, p: Not Significant: NS). During the same period, compared to CP scores, the reduction in TP group was higher by 37.7%, 58.4%, and 73.5% for rTNSS; 38.3%, 54.6%, and 64.1% for rTOSS and 29.84%, 48.91%, and 59.77% for am-iTOSS (p<0.05 for all parameters vs. CP at the same time points). The rhinoconjunctivitis quality of life questionnaire (RQLQ), measured using standard established questionnaire, was improved by 50.28% in TP group compared to 22.85% in CP group. During the study period, at least one rescue medicine was used by 80% patients in CP group compared to only 29% in TP group. Both products were well tolerated and induced no undesired effects. Conclusion:In the absence of any cell-friendly, safe, and multi-target treatment for allergic rhinitis, using a mechanically acting, filmogen barrier solution capable of blocking new allergen contact and minimizing the concentra...