Introduction/Background Papilocare®, a vaginal gel with Coriolus versicolor, has shown its ability to significantly influence the re-epithelialization of the cervix and the rebalancing of the vaginal microbiota that favors the natural process of vaginal immunity. Based on these data, the hypothesis was established that its application could positively influence the regression of HPV-dependent cervical atypia (ASCUS and LSIL) and associated colposcopic alterations, and the clearance of high-risk HPV (HPV- AR).

Methodology Single-center, randomized, open, parallel, and controlled clinical trial (Paloma Clinical Trial). women not vaccinated against HPV and HPV positive, between 30 and 65 years of age, and with a cytological result of ASCUS or LSIL and significant and concordant colposcopy.

- Papilocare® 1 cannula/day for 1 month + 1 cannula/every other day for 5 months.

-Control group no treatment, usual clinical practice.

The cytology and HPV reading was performed centrally in the HJRJ laboratory. The Chi-square test was used.

Results A total of 20 patients (mean age 41.3 years) with determined HPV genotype were evaluated.

-80% (8/10) of the patients treated with Papilocare® had cytology normal with concordant colposcopy at 6 months, versus 50% (5/10) in the control group, p = 0.001.

HR-HPV clearance was observed in 70% of cases (7/10) of patients treated with Papilocare® versus 40% (4/10) found in the control group, p = 0.02

Conclusion Papilocare® has demonstrated statistically significant efficacy in normalizing cervical cytological atypia (ASCUS/LSIL) and associated HPV-dependent colposcopic lesions. This rate of normalization was even higher in the HR-HPV subpopulation, in which a positive trend in clearance was also observed. HR-HPV at 6 months

Disclosures -