Article Text

Download PDFPDF
957 Satisfaction and tolerability of a coriolus versicolor-based vaginal gel in the PALOMA & PAPILOBS studies
  1. Santiago Palacios1,
  2. Javier De Santiago2 and
  3. Javier Cortés3
  1. 1Instituto Palacios, Salud y Medicina de la Mujer, Madrid, Spain
  2. 2MD Anderson Cancer Center, Madrid, Spain
  3. 3Private Practice, Palma, Spain


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 .

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.