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

NCT06399341 | Completed

• 1 other identifier: 2021-PPL-EL-130
• Study Type: observational
• Target: 524
• Locations: 1 country
• Sites: 4

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.

Conditions

Papillomavirus Infections

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Assessment of ΗPV clearance

  Assessment at 6 months (or at 12 months).

• The assessment of patient satisfaction level from treatment

  Assessment at 6 months (or at 12 months).

• The assessment of device safety

  Treatment period (6 or 12 months).

Other Outcomes (1)

• The assessment of biopsy results (where available)

  Assessment at 6 months (or at 12 months).

Study Arms (1)

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

Interventions

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)

Adult women with ASCUS or LSIL result in routine Pap-test.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 who, due to this condition, undergo a colposcopy and have a concordant result with cytology.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (4)

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

University General Hospital of Larissa

Larissa, 41110, Greece

Location

University General Hospital of Patra

Pátrai, 26504, Greece

Location

"HIPPOKRATION" General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Related Publications (2)

• 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.

  PMID: 24977385 BACKGROUND

• 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.

  PMID: 33746195 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandros Ginis, MD

  Elpen Pharmaceutical Co. Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: September 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

GR (4)