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

May 1, 2024 updated by: Elpen Pharmaceutical Co. Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

524

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
      • Patra, Greece, 26504
        • University General Hospital of Patra
      • Thessaloniki, Greece, 54642
        • "Hippokration" General Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women over 18 years old with positive HPV with lesions in the cervical mucosa, and concordant colposcopy findings are eligible for the study.

Description

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®.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Papilocare 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment at 6 months (or at 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment at 6 months (or at 12 months).
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.
Assessment at 6 months (or at 12 months).
The assessment of device safety
Time Frame: Treatment period (6 or 12 months).
Recording of adverse events throughout the treatment period.
Treatment period (6 or 12 months).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment at 6 months (or at 12 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elpen Pharmaceutical Co. Inc.

Investigators

  • Study Director: Alexandros Ginis, MD, Elpen Pharmaceutical Co. Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-PPL-EL-130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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