The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation. This clinical study is aimed at: * to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated? * to evaluate the safety and tolerance after local application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Local application of the experimental gel or placebo gel.
Hôpital Saint Pierre
Brussels, Brussels Capital, Belgium
CHU Brugmann
Brussels, Brussels Capital, Belgium
Hôpital Erasme
Brussels, Brussels Capital, Belgium
HIS Ixelles
Ixelles-Elsene, Brussels Capital, Belgium
Efficacy at week 12: change of histological and cytological parameters (success or not)
Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.
Time frame: 12 weeks
Efficacy at week 28: recurrence rate
The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.
Time frame: 28 weeks
Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)
Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.
Time frame: during 30 weeks
Virological status (infection)
The viral load and genotypes of HPVhr will be determined before treatment, during follow-up and at the end of the study, by using a quantitative analysis.
Time frame: during 30 weeks
Changes in lesion (colposcopic changes)
Colposcopic description of lesion will be done before, during and after treatment of the lesion, during follow up and at the end of the study.
Time frame: during 30 weeks
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CHU Charleroi Hôpital Civil
Charleroi, Charleroi, Belgium
CHU Charleroi Site André Vésale
Montigny-le-Tilleul, Charleroi, Belgium
CHU Tivoli
La Louvière, La Louvière, Belgium
CHU ND des Bruyères
Chênée, Liege, Belgium
CHR Citadelle
Liège, Liege, Belgium