Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study is a multicenter, open, non-interventional, prospective observational clinical study for the evaluation of the effectiveness of Papilocare® (medical device with CE mark) in the regression of cervix cytological abnormalities caused by HPV.
524 participants were enrolled in the study from approximately 44 Greek sites. At baseline (Visit 1) written informed consent was obtained, participants' eligibility criteria were checked and medical history data were collected. Participants were advised to be treated with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months). At 6 months (Visit 2) primary and secondary objectives were evaluated. If needed and based on physician's decision, treatment was extended to a total of 12 months (Visit 3) and primary and secondary endpoints were evaluated as well.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult women with ASCUS or LSIL result in routine Pap-test. | Adult HPV-positive women with Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low-grade Squamous Intraepithelial Lesions (LSIL) cervical cytology with concordant colposcopy were treated with Papilocare for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months), extending to a total of 12 months if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papilocare vaginal gel | Device | Treatment with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV. | The percentage of patients with normalized cytology with respective colposcopy findings, as a change from ASCUS or LSIL to normal cytology supported by colposcopy. | Assessment at 6 months (or at 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of ΗPV clearance | The percentage of patients with complete or partial clearance of HPV confirmed by molecular HPV test (PCR or genetic diagnostic kits) that can detect High Risk (HR) strains. | Assessment at 6 months (or at 12 months). |
| The assessment of patient satisfaction level from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The assessment of biopsy results (where available) | The percentage of patients who improve and / or those who maintain the same degree of histological lesion at 6 months or 12 months from baseline. | Assessment at 6 months (or at 12 months). |
Inclusion Criteria:
Women over 18 years of age who have been or not vaccinated against HPV.
Exclusion Criteria:
Women
Not provided
Women over 18 years old with positive HPV with lesions in the cervical mucosa, and concordant colposcopy findings are eligible for the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandros Ginis, MD | Elpen Pharmaceutical Co. Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Ioannina | Ioannina | 45500 | Greece | |||
| University General Hospital of Larissa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24977385 | Background | Agorastos T, Chatzistamatiou K, Zafrakas M, Siamanta V, Katsamagkas T, Constantinidis TC, Lampropoulos AF; LYSISTRATA study group. Epidemiology of HPV infection and current status of cervical cancer prevention in Greece: final results of the LYSISTRATA cross-sectional study. Eur J Cancer Prev. 2014 Sep;23(5):425-31. doi: 10.1097/CEJ.0000000000000060. | |
| 33746195 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Changes in a 10-point satisfaction scale (0: "not satisfied at all", 10: "completely satisfied") from inclusion date. |
| Assessment at 6 months (or at 12 months). |
| The assessment of device safety | Recording of adverse events throughout the treatment period. | Treatment period (6 or 12 months). |
| Larissa |
| 41110 |
| Greece |
| University General Hospital of Patra | Pátrai | 26504 | Greece |
| "HIPPOKRATION" General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| Serrano L, Lopez AC, Gonzalez SP, Palacios S, Dexeus D, Centeno-Mediavilla C, Coronado P, de la Fuente J, Lopez JA, Vanrell C, Cortes J. Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women With Human Papillomavirus-Dependent Cervical Lesions: The PALOMA Study. J Low Genit Tract Dis. 2021 Apr 1;25(2):130-136. doi: 10.1097/LGT.0000000000000596. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |