Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients
To evaluate the effectiveness of local treatment with carboxymethyl-b-glucan and polycarbophil on the clearance time of human papillomavirus (HPV), as well as on the normalisation of cytological alterations identified at study inclusion.
Study Type
OBSERVATIONAL
Enrollment
533
It is a vaginal spray gel designed for the prevention and treatment of cervical lesions caused by HPV. This is achieved by controlling the physiological conditions of the transformation zone of the cervico-vaginal mucosa. The composition of the gel, which includes polycarbophil and carboxymethyl-beta-glucan, effectively shields the cervico-vaginal mucosa from the damaging effects of external agents due to its bioadhesive capacity. Additionally, it contributes to the re-epithelialization and regression of cervical lesions
Hospital CIMA, Barcelona
Barcelona, Spain
Hospital Quirón San José
Madrid, Spain
Hospital Universitario Infanta Leonor,
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Quirón Donostia
Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophil.
Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype
Time frame: 6 months
Normalization rate of abnormal colposcopy
Evaluation of abnormal or normal colposcopy
Time frame: 6 Months
Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time
Change in the incidence of cytological alterations development measured by reflex cytology test (Normal Cytology; ASCUS; LSIL or HSIL cytology)
Time frame: 6 Months
Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV
Evaluation of HPV total negativization rate by HPV PCR test with genotype
Time frame: 6 Months
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San Sebastián, Spain