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

NACompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

November 17, 2020

Primary Completion Date

May 17, 2023

Study Completion Date

May 17, 2023

Conditions
Squamous Intraepithelial Lesions of the CervixHuman Papilloma Virus InfectionCervix Lesion
Interventions
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."

Trial Locations (1)

45000

Centre Hospitalier Régional d'Orléans, France, Orléans

All Listed Sponsors
lead

Centre Hospitalier Régional d'Orléans

OTHER

NCT04624568 - Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance | Biotech Hunter | Biotech Hunter