Introduction/Background*HPV clearance and resolution of cervical HPV-dependent lesions become difficult in peri and postmenopausal women. The objective of this sub-analysis was to evaluate the effect of the Papilocare®, a multi-ingredient Coriolus versicolor-based vaginal gel in repairing the HPV-dependent low-grade cervical lesions in women over 40 years.
Paloma study (ClinicalTrials gov NCT04002154) was a multicenter, randomized, open-label, parallel-group, watchful waiting approach-controlled clinical trial. Unvaccinated HPV positive women aged between 30-65 with cytology of ASCUS or LSIL and 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: watchful waiting approach (usual clinical practice). Primary endpoint:% of patients with normal cytology and concordant colposcopy after 6 months of treatment in the total population, high-risk (HR) HPV (16,18,31,33,35,39,45,51,52,56,58,59,68) and very HR HPV (patients infected by any combination of 16, 18 and 31) subpopulations. Pap smear evaluations were blind and centrally conducted by an independent researcher at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined as treatment group.
Result(s)*A total of 38 out of 84 evaluable patients at 6 months included in Paloma trial were above 40yo [mean(SD) age: 47.71(5.56)], of which 30 and 13 were HR HPV and 16-18-31 HPV patients, respectively. At 6 months, normal cytology and concordant colposcopy was observed in 92%, 90% and 75% of patients treated with Papilocare® vs 50%, 33% and 40% of patients in control group, in the total, HR and 16-18-31 populations (p=0.0066; p=0.0031; p=0.2929, Fisher test) respectively.
Conclusion*Papilocare® showed a robust and clinically significant efficacy in repairing cervical HPV lesions in women over 40 years, with a statistically significant difference vs control group in the total and HR populations.
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