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

January 9, 2024 updated by: Uriach Consumer Healthcare

Evaluation of the Efficacy and Safety of the Local Treatment of Carboxymethyl Beta-glucan and Polycarbophil in Patients With Normal Cytology/ASCUS/LSIL (CIN1) With HPV+ PCR Determination

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital CIMA, Barcelona
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28002
        • Hospital Quirón San José
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor,
      • San Sebastián, Spain, 20012
        • Hospital Quirón Donostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The data will be collected from patients who meet the selection criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CONTROL GROUP
For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment.
TREATMENT GROUP
For a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months
Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normalization rate of abnormal colposcopy
Time Frame: 6 Months
Evaluation of abnormal or normal colposcopy
6 Months
Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time
Time Frame: 6 Months
Change in the incidence of cytological alterations development measured by reflex cytology test (Normal Cytology; ASCUS; LSIL or HSIL cytology)
6 Months
Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV
Time Frame: 6 Months
Evaluation of HPV total negativization rate by HPV PCR test with genotype
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uriach Consumer Healthcare

Investigators

  • Principal Investigator: Carmen Pingarrón Santofima, Doctor, Hospital Quirón San José

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Actual)

September 22, 2023

Study Completion (Actual)

November 22, 2023

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Fix Study V.2 12/Jul/2022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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