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Completed

NCT Number: NCT06399341

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

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.

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Key information

Conditions

Papillomavirus Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University General Hospital of Ioannina, Ioannina, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women over 18 years of age who have been or not vaccinated against HPV.

  • Able to read and understand the Informed Consent Form and agree to participate in the study by signing the Informed Consent Form.
  • 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.
  • Patients who, due to this condition, undergo a colposcopy and have a concordant result with cytology.

Exclusion criteria

  • 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.
  • 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.
  • Women who use vaginal contraceptives or other vaginal hormone treatments during the study.
  • Participation in another clinical trial either currently or 4 weeks before enrolling in the study.
  • Any scheduled surgery that precludes compliance with treatment.
  • Known allergies to any of the ingredients of Papilocare®.

Treatment and study plan

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)

Primary outcomes

  1. The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV.

    Time frame: 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 outcomes

  1. Assessment of ΗPV clearance

    Time frame: 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.

  2. The assessment of patient satisfaction level from treatment

    Time frame: 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.

  3. The assessment of device safety

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

    Recording of adverse events throughout the treatment period.

Other outcomes

  1. The assessment of biopsy results (where available)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study title

PAPILOBS GR: A Clinical Investigation to Assess the Effectiveness of PAPILOCARE® in the Regression of Cervix Cytological Abnormalities Caused by HPV.

Acronym: PAPILOBSGR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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