CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
PAPILOCAREdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04624568
NCT04624568N/ACompleted
CompareCT.gov

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

Centre Hospitalier Régional d'Orléans·interventional·Posted Nov 12, 2020·Updated Jun 15, 2023

In Brief

A clinical study evaluating PAPILOCARE for Squamous Intraepithelial Lesions of the Cervix and 2 related conditions. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Intraepithelial Lesions of the Cervix, Human Papilloma Virus Infection, Cervix Lesion
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 12, 2020
Enrollment StartNov 17, 2020
Primary CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.6 years ago

Interventions

PAPILOCAREdevice

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.