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Clinical Outcomes of a Multi-Ingredient Coriolus versicolor-Based Vaginal Gel in Greek Women with Low-Grade Cervical Lesions: The PAPILOBS-GR Real-Life Prospective Study
by
, , , ,
Georgios Michail
1,*
,
Alexandros Daponte
2,
George Valasoulis
2
,
Konstantinos Dinas
3,
Evripidis Bilirakis
4,
Kalliopi Pappa
5,
Konstantinos Chronopoulos
6,
Christodoulos Akrivis
7,
Zoi Anastasiadi
7,
Marinos Nikolaou
8,
Antonios Garas
2,
Thomas Tsiantis
9,
Antonios Athanasiou
9,
Maria Bertoli
10,
Alexandros Ginis
10 and
Evangelos Paraskevaidis
9 
1
Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Patras, General University Hospital of Patras, 26504 Rion, Greece
2
Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Thessaly, University Hospital of Larissa, 41334 Larissa, Greece
3
2nd Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Hippokration General Hospital, 54642 Thessaloniki, Greece
4
Department of Obstetrics and Gynaecology, IASO Hospital, 15123 Athens, Greece
5
1st Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, National and Kapodistrian University of Athens, Alexandra University Hospital, 11528 Athens, Greece
6
Department of Obstetrics and Gynaecology, General Hospital of Argolida-Argos Nursing Unit, 21100 Argos, Greece
7
Department of Obstetrics and Gynaecology, General Hospital of Ioannina G. Hatzikosta, 45445 Ioannina, Greece
8
Department of Obstetrics and Gynaecology, General Hospital of Agios Nikolaos, 72100 Agios Nikolaos, Greece
9
Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Ioannina, University Hospital of Ioannina, 45500 Ioannina, Greece
10
Medical Department, ELPEN Pharmaceutical Co., Inc., 19009 Attica, Greece
*
Author to whom correspondence should be addressed.
Cancers 2026, 18(17), 2762; https://doi.org/10.3390/cancers18172762
Submission received: 23 July 2026
/
Revised: 18 August 2026
/
Accepted: 20 August 2026
/
Published: 25 August 2026
(This article belongs to the Special Issue Human Papillomavirus (HPV) and Related Cancer)
Simple Summary
Low-grade cervical lesions are typically managed through surveillance rather than active treatment. However, persistent HPV infection and cervical abnormalities remain a clinical concern for some women, and monitoring alone can be associated with considerable patient anxiety. This observational study expands the clinical evidence for Coriolus versicolor-based vaginal gel, a non-hormonal vaginal gel designed to promote tissue regeneration and microbiota balance. Data from a large multicenter cohort in Greece confirmed that a substantial proportion of treated patients achieved lesion regression and HPV clearance. Notably, these clinical benefits were consistent regardless of vaccination status, age, or viral risk level. Despite the limitations of the study, these findings suggest that this vaginal gel may represent a promising adjunctive approach for women with low-grade cervical lesions, while supporting its favorable safety profile. However, further randomized controlled studies are required to confirm its efficacy and define its potential role in clinical practice.
Abstract
Background: Persistent human papillomavirus (HPV) can cause low- or high-grade cervical lesions, which may progress to cervical cancer. This prospective, multicenter, real-world study assessed the effectiveness, tolerability and safety of a Coriolus versicolor-based vaginal gel for the regression of HPV-related low-grade cervical lesions in routine Greek practice. Methods: PAPILOBS-GR is a multicenter, open-label, non-interventional, prospective observational, non-comparative study conducted across 45 sites in Greece. Women aged ≥18 years with ASCUS/LSIL cytology and concordant colposcopy were enrolled. Participants received Coriolus versicolor-based vaginal gel for six months. A second 6-month cycle was offered if needed. The primary endpoint was lesion regression. Secondary endpoints included HPV clearance, patient satisfaction, biopsy evolution, tolerability, and safety. Results: Of 524 enrolled patients (mean age: 34.4 ± 10.0 years; 40.5% HR-HPV), 494 (94.3%) completed the study. Overall, 75.9% achieved lesion regression (72.1% at 6 months and 34.0% at 12 months). HPV clearance occurred in 72.0% overall (68.1% at 6 months and 50.0% at 12 months). Exploratory comparisons showed generally consistent effectiveness across subgroups, including women with HR-HPV, those aged >40 years, and vaccinated participants. No significant differences in clinical endpoints were observed in association with age or vaccination status. Among 22 patients with baseline and 12-month biopsies, 59.1% showed histological improvement. Satisfaction scores exceeded 8/10 at 6- and 12-month follow-ups. Only two non-serious possibly product-related adverse events were reported. Conclusions: Coriolus versicolor-based vaginal gel was associated with high rates of lesion regression and excellent tolerability, reinforcing previous clinical findings and supporting its potential role as an adjunctive approach during watchful waiting for HPV-positive low-grade cervical lesions.
