Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

533 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-11-22

Brief Summary

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Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients

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RECRUITING PHASE4

Detailed Description

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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.

Conditions

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Human Papillomavirus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CONTROL GROUP

For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment.

No interventions assigned to this group

TREATMENT GROUP

For a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil

carboxymethyl β-glucan

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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carboxymethyl β-glucan

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No