Introduction/Background The multi-ingredient Coriolus versicolor-based vaginal gel (Papilocare®) was the first available treatment for the prevention and treatment of low-grade HPV-dependent cervical lesions. Within both the PALOMA and PapilOBS studies, we wanted to evaluate the satisfaction and tolerability of this vaginal gel.

Methodology The PALOMA study (NCT04002154) was a multicenter, randomized, open-label, parallel-group, ‘wait and see’ approach-controlled clinical trial. Unvaccinated HPV-positive women aged 30–65 y/o with cytology of ASCUS/LSIL and concordant colposcopy image were included. The PapilOBS study (NCT04199260) was an observational, multicenter, prospective, one-cohort study. Vaccinated or not HPV-positive women aged over 25 y/o with cytology of ASCUS/LSIL and concordant colposcopy were included. Patients in the PALOMA study were asked to complete a seven-point Likert scale, ranging from 1 (very satisfied) to 7 (not satisfied at all). Similarly, patients in the PapilOBS study completed a visual analogue scale ranging from 0 (not satisfied at all) to 10 (very satisfied). Tolerability was assessed through the registry of adverse events (AE) in both studies.

Results A total of 52 patients from the PALOMA study answered the satisfaction questionnaire. 75.9% of the patients were very satisfied or satisfied, 9.6% slightly satisfied and 11.5% without changes. None of the patients was dissatisfied with the treatment. Patient satisfaction in the PapilOBS study was evaluated in 191 patients with a score of 7.5–8 out of 10. Eight patients reported 10 AE probably related to the use of Papilocare®. Most of them (n=9) were vulvovaginal itching, burning and irritation; the intensity of which was mild to moderate.

Conclusion Patients showed a high degree of satisfaction with Papilocare® vaginal gel in both studies and indicated a favourable tolerability profile.

Disclosures .