Human Papillomavirus Infection
Conditions
Keywords
HPV
Brief summary
Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients
Detailed description
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
TREATMENT GROUP INCLUSION: * Women aged between 25 and 65 years (inclusive). * Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). * Patients currently undergoing treatment with the combination of carboxymethyl B-glucan and polycarboxyl (for at least 15 days prior to study initiation) * Capable of reading and comprehending the patient information sheet and the informed consent form. * Willing to participate in the study and sign the informed consent form. EXCLUSION: * Cervical cytology indicating suspected invasive cervical cancer. * Ongoing or recent pregnancy terminated within six weeks of the study commencement. * Clinically significant immunodeficiency-linked pathology. * Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry. * Undiagnosed abnormal genital bleeding. * Total hysterectomy. * Documented history of cervical pathology caused by HPV. * Contraindications to the use of the combination of Carboxymethyl B-glucan and polycarboxyl, or known allergies to any of its components. CONTROL GROUP INCLUSION: * Women aged between 25 and 65 years (inclusive). * Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). * Patients not currently undergoing treatment for HPV. * Capable of reading and comprehending the patient information sheet and the informed consent form. * Willing to participate in the study and sign the informed consent form. EXCLUSION: * Cervical cytology indicating suspected invasive cervical cancer. * Ongoing or recent pregnancy terminated within six weeks of the study commencement. * Clinically significant immunodeficiency-linked pathology. * Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry. * Undiagnosed abnormal genital bleeding. * Total hysterectomy. * Documented history of cervical pathology caused by HPV. * Concurrent participation in a clinical study of an investigational drug that could interfere with the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months | Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalization rate of abnormal colposcopy | 6 Months | Evaluation of abnormal or normal colposcopy |
| Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time | 6 Months | Change in the incidence of cytological alterations development measured by reflex cytology test (Normal Cytology; ASCUS; LSIL or HSIL cytology) |
| Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV | 6 Months | Evaluation of HPV total negativization rate by HPV PCR test with genotype |
Countries
Spain