Clinical Evaluation of the Efficacy and Safety of a Medical Vaginal Device Containing Rigenase^® for the Treatment of Vaginosis: A Randomized Study

Abstract

Background: Vaginitis is an inflammatory process involving the vagina, expanding often to the contiguous anatomical structures (cervix and vulva). From an etiological point of view, there are mainly two types of vaginitis: specific vaginitis (due to pathogenic microorganisms) and non-specific vaginitis (also defined vaginosis), usually caused by an alteration (disruption) of the normal vaginal microflora, usually represented by the presence of Lactobacilli due to opportunist bacteria proliferation. Whereby, the first line therapeutic approach for vaginosis (which is frequently subject to self-medication) should be focused on rebalancing the flora and not on antimicrobials, reserving the latter to persistent cases that are properly characterized by appropriate microbiological tests. A new medical device is available in different formulations for the local treatment of vaginitis and, in addition, of irritative-dystrophic states of the vaginal area.

Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

“…Usually intra-vaginal medical devices in traditional pharmaceutical forms (suppositories, tablets, capsules, etc.) are developed for correction (restoration) of vaginal microbiota [24][25][26]. Other indications for such devices include promotion of fertilization [27], delivery of anti-HIV drugs [28], etc.…”

Clinical performance and safety of Cerviron®vaginal ovules in the local treatment of non-specific vaginitis: a national, multicentric clinical investigation

“…The purpose of treatment in both non-specific vaginitis and non-infectious vaginitis is to restore the vaginal microbiome and to reduce the signs and symptoms associated with inflammation. Several vaginal topical treatments were marketed until date to treat vaginal microbiome dysbiosis [16,17]. Among other potential interventions, vaginal microbiota transplantation shows the advantage of completely restoring the microbiome to a healthy state but there is still insufficient clinical evidence to translate this procedure into clinical practice [18].…”

In Vitro Characterization of a Novel Medical Device in Simulated Vaginal Environment

“…Earlier data [17] documented the ability of Fitostimoline® Septagel to restore the state of well-being in patients with inflammatory-dystrophic vaginal disorders, due to the presence of Rigenase® in the formulation of this hydrogel that is the fundamental ingredient that gives the additional ability to create a favorable condition for a rapid and correct re-epithelization of the vaginal epithelium. Rigenase® is a specific aqueous extract isolated by Farmaceutici Damor from the natural source of T. vulgare that exhibits a moisturizing action and a scavenging effect toward free radicals, thus pointing to its relevant antioxidant activity [18].…”

“…Rigenase®, a Farmaceutici Damor's trademark, is a Triticum vulgare extract that exercises a refreshing and lenitive action, and in addition, promotes tissue repairing and cellular microenvironment recovery, concurring to the reconstitution of the normal vaginal flora and of the physiologic acid pH [17]. In addition, Rigenase® exhibits antioxidant capacity by tissue-repairing activity and moisturizing action [18].…”