NCT04624568

Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance

Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

clinical trial comparing the regression rate after 12 months of histologically confirmed cervical intraepithelial lesions 1 in 2 parallel groups. One group using the vaginal gel Papilocare® for 6 months and one group without any treatment.

Detailed description

Cervical cancer affects 3000 women and causes 1100 deaths every year in France. This type of cancer usually takes about 10 to 15 years to develop and has distinct precursor stages. Persistent infection by Human Papillomavirus is necessary for the development of these lesions. Currently, when a colposcopy biopsy reveals low grade lesion, it is recommanded to make a new cervical cytology or HPV testing, 12 months later. No treatment is recommended over this period. However 11% of these lesions evolve from low to high grade. Papilocare® is a vaginal gel that would improve the re-epithelialization of the uterine cervix. Creating a protective film on the cervix, it could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus. The goal of our study is to include 150 women with a histologically confirmed cervical intraepithelial lesions 1. Half of them will be using the vaginal gel Papilocare® for 6 month while the other half will not receive any treatment (as suggested by current recommendations). Each patient will have a cervical cytology and a HPV testing after 6 months and after 12 months. Therefore we will be able to compare the percentage of normalization of cervical cytology and HPV clearance for each group after 6 months and after 12 months. Patients will visit the Orleans hospital once for the inclusion and twice for follow-ups after 6 months and 12 months. If the use of Papilocare® really induces a significant regression of low grade lesions, this vaginal gel could be offered as soon as these lesions are histologically identified in order to stop its progress to high grade.

Conditions

• Squamous Intraepithelial Lesions of the Cervix
• Human Papilloma Virus Infection
• Cervix Lesion

Interventions

Type	Name	Description
DEVICE	PAPILOCARE	Papilocare® is a self-administered vaginal gel. Its single-dose cannula contains hyaluronic acid and pre-biotics (Coriolus Versicolor) that would improve the re-epithelialization of the uterin cervix. By creating a protective film on the cervix, this gel could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus. The specific approach related to our study would be to apply Papilocare® vaginal gel for 6 months for the treated group. Smear and HPV test will be perform by all patients at 6 and 12 months.

Timeline

• Start date: 2020-11-17
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2020-11-12
• Last updated: 2023-06-15

Locations

1 site across 1 country: France