To evaluate the effect of a Coriolus versicolor-based vaginal gel (Papilocare®) on cervical epithelialization in positive-HPV women with no colposcopy lesions.
An exploratory, prospective, observational study. Sexually active positive-HPV women aged > 25y with negative pap and no colposcopy cervical lesions were included during routine clinical visits and treated with Papilocare® once daily for 21 consecutive days. Primary endpoint: change vs baseline in epithelialization degree of the cervix mucosa evaluated by standard colposcopy and rated by investigator from 5 = No ectopy o 1= severe ectopy and bleeding. Secondary endpoints: 1) changes in vaginal signs and symptoms evaluated by likert-type scale from 7= severity to 28= absence, 2) changes in vaginal microbiota evaluated by pyrosequencing and 3) patient satisfaction.
21 patients were included. Papilocare® showed a positive trend to improve the re-epithelialization of the cervix: mean score improved 20% (3.79 vs 4.47 baseline vs final; T test p<0.006). 52.6% of patients improved cervix epithelialization and a score of 5 was observed in 63% of women. A trend to improve symptoms was observed despite of few symptoms at baseline: 71% of patients reached maximum symptoms score at the end of treatment period. Eight patients improved the symptoms score and 3 worsened. A “moderate/complete satisfaction” and some degree of «positive impact on wellness» were reported by 84% and 90% of evaluated patients, respectively. Vaginal microbiota analysis is currently ongoing.
In this pilot study, Papilocare® shows promising benefits in the variables analyzed; these findings need to be confirmed in a larger study.