KEY TAKEAWAYS
- The PALOMA and Papilobs trials aimed to assess the efficacy of Papilocare®, a multi-ingredient Coriolus versicolor-based vaginal gel, in repairing low-grade cervical lesions associated with high-risk HPV in women aged over 40.
- The result demonstrated that the gel effectively repairs cervical HR-HPV lesions in older women compared to watchful waiting.
In menopausal women, achieving HPV clearance and resolving HPV-dependent cervical lesions becomes challenging. Researchers aimed to assess the efficacy of Papilocare®, a multi-ingredient Coriolus versicolor-based vaginal gel, in repairing low-grade cervical lesions associated with high-risk HPV in women aged over 40.
The Paloma study included unvaccinated HPV-positive women aged 30-65 patients with ASCUS or LSIL cytology and matching colposcopy images. Patients were assigned to 3 groups: A) Coriolus versicolor-based vaginal gel for 1 month followed by alternate days for 5 months; B) 3 months of daily gel followed by alternate days for 3 months; C) a control group with watchful waiting.
The Papilobs study was an observational cohort study for HPV-positive women over 25 with ASCUS or LSIL cytology and concordant colposcopy. All received the Coriolus versicolor-based vaginal gel for 21 days in the first month and then alternate days for 5 months. A sub-analysis focused on HR-HPV-positive individuals over 40 included participants from both studies.
In the Paloma study, among HR-HPV patients over 40, the A+B groups demonstrated normal cytology and concordant colposcopy in 90% compared to 33% in the control group (P=0.003, Fisher test). In the Papilobs study, 73.5% of patients achieved normal cytology and concordant colposcopy.
The result demonstrated that the gel effectively repairs cervical HR-HPV lesions in older women compared to watchful waiting, demonstrated in clinical trials and real-world settings.
Source: https://www.emma.events/site/programme/?sessiondetail=4534565&trackid=0&a=esgo2023#!
Clinical Trials: https://clinicaltrials.gov/study/NCT04002154
https://clinicaltrials.gov/study/NCT04199260
Palacios S, Cortés J, De Santiago J. Efficacy of a multi-ingredient Coriolus versicolor-based vaginal gel in high-risk HPV women over 40: A sub-analysis of the Paloma clinical trial & Papilobs real-life study.
