698 Real-life efficacy of a multi-ingredient coriolus versicolor-based vaginal gel in high-risk HPV patients: the PAPILOBS study final results

Abstract

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.

Efficacy of a Coriolusversicolor-Based Vaginal Gel in Human Papillomavirus-Positive Women Older Than 40 Years: A Sub-Analysis of PALOMA Study

“…Cortés et al have recently presented the results of an observational, prospective, non-controlled study called PAPILOBS (clinicalTrials.gov: NCT04199260) in Spain [ 14 , 20 ]. The study included vaccinated or not women over 25 years who tested positive for HPV and with Pap smear of ASCUS or LSIL and concordant colposcopy image.…”

“…In this context, Papilocare ® (Procare Health, Barcelona, Spain), a vaginal gel including Coriolus versicolor and other ingredients, has proven to be effective and safe in repairing low-grade cervical lesions and enhancing HR-HPV clearance [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. The objective of the present study was to evaluate the efficacy of the vaginal gel in repairing the HPV-dependent low-degree cervical lesions and clearing the HPV in women aged older than 40 years from the PALOMA study (NCT04002154).…”