NCT06399341

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 524 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

4 sites across 1 country: Greece