Introduction/Background To evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- in repairing HPV-dependent cervical lesions (ASCUS/LSIL) and in the clearance of high-risk HPV (HR-HPV).
Methodology Randomized, open-label, parallel-group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were 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) Control group: no treatment (usual clinical practice). Main results of the Paloma trial are presented: Percentage of patients with normal cytology and concordant colposcopy image at 6 months (primary endpoint), and percentage of patients with HR-HPV clearance at 6 months (clearance: total and partial clearance with concordant cytological normalization). Pap smear evaluation was being centrally-conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this per-protocol analysis.
Results A total of 84 all HPV genotype patients (total population) of which 66 with High Risk -HPV (HR-HPV subpopulation) were evaluated. In the total population, 85% (45/53) of patients treated with Papilocare® had normal cytology with concordant colposcopy vs. 65% (20/31) in control group (p=0.0311; Chi-square test; figure 1). In the HR-HPV subpopulation, normal cytology and concordant colposcopy image was observed in 88% (36/41) of patients treated with Papilocare® vs 56% (14/25) of control group patients (p=0.0034; Chi-square test; figure 2).
HR-HPV clearance was observed in 63% (25/40) vs 40% (10/24) of patients treated with Papilocare® vs. control group (p=0.07; Chi-square), respectively.
Conclusion Papilocare showed a statistically significant efficacy in normalizing HPV-dependent cervical lesions (ASCUS/LSIL) versus control group. The normalization rate of HPV-dependent lesions was even higher in the HR-HPV subpopulation, in which a positive trend in HR-HPV clearance was also observed at 6 months.
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