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

Papillomavirus Infections Clinical Trial

— PAPILOBSGR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399341
• Other study ID #: 2021-PPL-EL-130
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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®.

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

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)

Locations

Country	Name	City	State
Greece	University General Hospital of Ioannina	Ioannina
Greece	University General Hospital of Larissa	Larissa
Greece	University General Hospital of Patra	Patra
Greece	"HIPPOKRATION" General Hospital of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The assessment of biopsy results (where available)	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).
Primary	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	Assessment of ?PV 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.	Assessment at 6 months (or at 12 months).
Secondary	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.	Assessment at 6 months (or at 12 months).
Secondary	The assessment of device safety	Recording of adverse events throughout the treatment period.	Treatment period (6 or 12 months).