To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- to repair cervical mucosa in women with HPV-related pap alterations and consistent colposcopy image.
A randomized, open-label, parallel-group, controlled clinical trial. Currently recruiting 96 positive-HPV women age 30 to 65 with pap result of ASC-US or LSIL or AG-US and concordant colposcopy image, randomized into 3 groups: A) Papilocare® 1 cannula/day for 1 month + 1 cannula/alternate days for 5 months; B) Papilocare® 1 cannula/day for 3 months + 1 cannula/alternate days for 3 months; C) no treatment. Preliminary analysis of percentage of patients with normal pap and concordant colposcopy image at 3 months in both total and high risk genotype virus population are presented. Citologies evaluation has been centrally-conducted in IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this analysis.
Data from 41 patients at 3 months are available. 69.2% of patients using Papilocare® (n=26) had negative pap and colposcopy vs. 33.3% in control group (n=15) (p=0.048; Fisher test).
High risk genotypes virus were detected in 28 patients. At 3 months, normal pap and concordant colposcopy image was observed in 67% of patients using Papilocare® (n=18) vs 20% of patients in control group (n=10) (p=0.046; Fisher test).
In these preliminary results, Papilocare® shows a significant difference in repairing HPV-cervical lesions at 3 months versus control; these findings need to be confirmed upon study completion.