Papillomavirus Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPapilocare vaginal gel
Treatment with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months)
Sponsors
Elpen Pharmaceutical Co. Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women over 18 years of age who have been or not vaccinated against HPV. 1. Able to read and understand the Informed Consent Form and agree to participate in the study by signing the Informed Consent Form. 2. Patients with ASCUS or LSIL routine cytological examination and positive High Risk (HR) HPV molecular test, up to 3 months before inclusion in the study. 3. Patients who, due to this condition, undergo a colposcopy and have a concordant result with cytology.
Exclusion criteria
1. Any gynecological or non-gynecological condition / lesion / pathology for which, according to clinical judgment, the use of Papilocare® is not recommended or its use has contraindications. 2. Fertile women who do not use effective contraceptive methods, pregnant women, women with suspected pregnancy or intention to become pregnant within the next 6 months, or breastfeeding women. 3. Women who use vaginal contraceptives or other vaginal hormone treatments during the study. 4. Participation in another clinical trial either currently or 4 weeks before enrolling in the study. 5. Any scheduled surgery that precludes compliance with treatment. 6. Known allergies to any of the ingredients of Papilocare®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV. | Assessment at 6 months (or at 12 months) | The percentage of patients with normalized cytology with respective colposcopy findings, as a change from ASCUS or LSIL to normal cytology supported by colposcopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of ΗPV clearance | Assessment at 6 months (or at 12 months). | 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. |
| The assessment of patient satisfaction level from treatment | Assessment at 6 months (or at 12 months). | Changes in a 10-point satisfaction scale (0: not satisfied at all, 10: completely satisfied) from inclusion date. |
| The assessment of device safety | Treatment period (6 or 12 months). | Recording of adverse events throughout the treatment period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The assessment of biopsy results (where available) | Assessment at 6 months (or at 12 months). | 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. |
Countries
Greece
Outcome results
None listed