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

ELPEN

Status: Completed

Conditions: Papillomavirus Infections

Treatments: Device: Papilocare vaginal gel

Study type: Observational

Funder types: Industry

Identifiers

NCT06399341

2021-PPL-EL-130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 524 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®.

Trial design

524 participants in 1 patient group

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

Description:

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.

Treatment:

Device: Papilocare vaginal gel