Clinical trial NCT06399341: Clinical Effectiveness of PAPILOCARE® in Regression of Cervix HPV Cytological Abnormalities (PAPILOBS GR).
Official title: PAPILOBS GR: A Clinical Investigation to Assess the Effectiveness of PAPILOCARE® in the Regression of Cervix Cytological Abnormalities Caused by HPV.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 524
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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®.

Primary outcomes:
measure: The assessment of effectiveness of PAPILOCARE® in the regression of cervix cytological abnormalities caused by HPV.
timeFrame: Assessment at 6 months (or at 12 months)
Secondary outcomes:
measure: Assessment of ΗPV clearance
timeFrame: Assessment at 6 months (or at 12 months).
measure: The assessment of patient satisfaction level from treatment
timeFrame: Assessment at 6 months (or at 12 months).
measure: The assessment of device safety
timeFrame: Treatment period (6 or 12 months).
Other outcomes:
measure: The assessment of biopsy results (where available)
timeFrame: Assessment at 6 months (or at 12 months).
Locations:
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Patra
country: Greece
facility: University General Hospital of Patra
city: Thessaloniki
country: Greece
facility: "HIPPOKRATION" General Hospital of Thessaloniki
Study officials:
affiliation: Elpen Pharmaceutical Co. Inc.
name: Alexandros Ginis, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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.