To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- to clear HPV at 6 months.
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 HPV clearance at 6 months in both total and high risk genotype virus population are presented. HPV genomic evaluation has been centrally-conducted in IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this analysis.
Data about HPV clearance from 26 patients are available. HPV clearance was observed in 56% of patients using Papilocare® (n=16) vs 30% in control group (n=10) (p=0.247; Fisher test).
High risk genotypes viruses were detected in 18 patients. At 6 months, 50% of patients in Papilocare® group (n=12) showed HPV clearance vs 17% (n=6) in control group (p=0.315; Fisher test).
In these preliminary results, Papilocare® shows a positive trend in HPV clearance at 6 months, especially in high risk genotype virus population; these findings need to be confirmed upon study completion.