Novel Non-Antibiotic Treatment of Bacterial Infections of the Vagina, A Proof of Concept Study using Single Dose and Triple Dose Regimen

Abstract

The effect of a novel treatment principle for bacterial vaginosis has been investigated in an open clinical study. 10 patients received a single dose while 20 patients received three applications every third day. The formulation is in the form of vaginal foam, containing lactic acid, hydrogen peroxide and an antimicrobial lipid. The intention of using the foam form for delivery is to avoid the creation of untreated areas, as is the case for other local formulations. Clinical signs, symptom and microbial effects have been studied using strict Amsel criteria and modified Hay/Ison for inclusion and modified Hay/Ison to monitor clinical efficacy pre- and post- menstruation. Therapeutic parameters as pH, malodor, abnormal discharge, itch and pain were monitored during the study. The microbiological was monitored by PCR being able to detect 6 pathogens and Lactobacilli.