Clinical Effectiveness of PAPILOCARE® in Regression of Cervix HPV Cytological Abnormalities (PAPILOBS GR).

Elpen Pharmaceutical Co. Inc.524 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

524

Conditions

Papillomavirus Infections

Interventions

Papilocare vaginal gelDEVICE

Treatment with Papilocare® for 6 months (1 cannula/day for 21 days during first month + 1 cannula/alternate days for subsequent 5 months)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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®.

Locations (4)

University General Hospital of Ioannina

Ioannina, Greece

University General Hospital of Larissa

Larissa, Greece

University General Hospital of Patra

Pátrai, Greece

"HIPPOKRATION" General Hospital of Thessaloniki

Thessaloniki, Greece

Outcomes

Primary Outcomes

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.

Time frame: Assessment at 6 months (or at 12 months)

Secondary Outcomes

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.

Time frame: Assessment at 6 months (or at 12 months).

The assessment of patient satisfaction level from treatment

Changes in a 10-point satisfaction scale (0: "not satisfied at all", 10: "completely satisfied") from inclusion date.

Time frame: Assessment at 6 months (or at 12 months).

The assessment of device safety

Recording of adverse events throughout the treatment period.

Time frame: Treatment period (6 or 12 months).

Data from ClinicalTrials.gov

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