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

  • STATUS
    Recruiting
  • End date
    May 18, 2023
  • participants needed
    90
  • sponsor
    Centre Hospitalier Régional d'Orléans
Updated on 18 November 2021
human papillomavirus
hpv vaccine
smear
colposcopy
low-grade squamous intraepithelial lesion

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.

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.

Details
Condition Cervical Dysplasia, Cervical Lesion, Cervix Lesion, Human Papillomavirus Infection, cervical lesions, Human Papilloma Virus Infection, HPV Infection, Cervical dysplasia
Treatment PAPILOCARE
Clinical Study IdentifierNCT04624568
SponsorCentre Hospitalier Régional d'Orléans
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women aged 25 years old or older
With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area
With complete colposcopy, performed less than 3 months prior the inclusion
With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy

Exclusion Criteria

Women under guardianship or curatorship
Women under the protection of justice
Women not affiliated with a social security system
Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of inclusion for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women
Immunodepressed women (HIV, immunosuppressive treatments ...)
Woman using vaginal contraceptives (ring, spermicides, cervical cap; because of risk of interaction) NB: Papilocare is compatible with the use of condoms and intrauterine devices
Known allergy to one of the components
Patients with low-grade histology with HSIL - ASC-H - AGC smear will not be included. The cyto-colposcopic discordance suggests a high-grade lesion that would not have been biopsied at colposcopy
Patients undergoing laser or conization treatment according to the recommendations of INCa 2016 will not be included; namely: persistence of CIN 1 for more than 24 months on at least 2 different colposcopies; high-grade squamous intraepithelial histological lesions; adenocarcinoma in situ
Participation in another interventional study
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