{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T17:12:03Z","timestamp":1788541923873,"version":"build-2803163510"},"reference-count":48,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T00:00:00Z","timestamp":1787616000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"ELPEN Pharmaceutical Co., Inc."},{"id":[{"id":"https:\/\/ror.org\/00w9t4e98","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>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 \u226518 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 \u00b1 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 &gt;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.<\/jats:p>","DOI":"10.3390\/cancers18172762","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T15:01:07Z","timestamp":1787670067000},"page":"2762","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3555-8867","authenticated-orcid":false,"given":"Georgios","family":"Michail","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Patras, General University Hospital of Patras, 26504 Rion, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandros","family":"Daponte","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Thessaly, University Hospital of Larissa, 41110 Larissa, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4444-3711","authenticated-orcid":false,"given":"George","family":"Valasoulis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Thessaly, University Hospital of Larissa, 41110 Larissa, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7144-2840","authenticated-orcid":false,"given":"Konstantinos","family":"Dinas","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Hippokration General Hospital, 54642 Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evripidis","family":"Bilirakis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, IASO Hospital, 15123 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalliopi","family":"Pappa","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantinos","family":"Chronopoulos","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, General Hospital of Argolida-Argos Nursing Unit, 21231 Argos, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christodoulos","family":"Akrivis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, General Hospital of Ioannina G. Hatzikosta, 45445 Ioannina, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoi","family":"Anastasiadi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, General Hospital of Ioannina G. Hatzikosta, 45445 Ioannina, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marinos","family":"Nikolaou","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, General Hospital of Agios Nikolaos, 72100 Agios Nikolaos, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonios","family":"Garas","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Thessaly, University Hospital of Larissa, 41110 Larissa, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Tsiantis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Ioannina, University Hospital of Ioannina, 45500 Ioannina, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonios","family":"Athanasiou","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Ioannina, University Hospital of Ioannina, 45500 Ioannina, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9096-7298","authenticated-orcid":false,"given":"Maria","family":"Bertoli","sequence":"additional","affiliation":[{"name":"Medical Department, ELPEN Pharmaceutical Co., Inc., 19009 Attica, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandros","family":"Ginis","sequence":"additional","affiliation":[{"name":"Medical Department, ELPEN Pharmaceutical Co., Inc., 19009 Attica, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Paraskevaidis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Ioannina, University Hospital of Ioannina, 45500 Ioannina, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,25]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2024). 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