Efficacy of Intravaginal Carboxymethyl-β-glucan and Polycarbophil on Low-grade Cervical Lesions (GLUCANCIN) (GLUCANCIN)

June 11, 2021 updated by: Uriach Consumer Healthcare

Evaluation of the Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil on the Regression of Low-grade Cervical Intraepithelial Lesions

A therapeutic strategy to neutralize the evasion mechanisms of HPV. Among these treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV. The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally, on the regression of low-grade cervical intraepithelial lesions (CIN) associated to HR-HPV infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background

Human papillomavirus (HPV) infection represents a significant source of morbidity and mortality worldwide. High-risk oncogenic HPVs cause 99.7% of cervical cancers. 80% of sexually active women will be infected with HPV at some point in their life. Most of these infections are transitory and only if they are persistent and caused by a high-risk oncogenic HPV are they an important risk factor for the development of cervical intraepithelial lesions and invasive cervical cancer. Immunity plays a key factor in eliminating HPV infection. The innate immune response constitutes the first line of defense against infection during the early stages of infection, promoting a cytokine-mediated inflammatory response which links innate immunity with the adaptive immune response. HPV evasion of these immune defense mechanisms is critical for the persistence of the infection and leads to the development of preneoplastic lesions and ultimately to cervical cancer. One of most promising treatments is beta-glucans that seem capable of affecting the course of HPV infection, and consequently, the progression of its associated intraepithelial lesions.

Justification

β-glucans are a very diverse heterogeneous group of polysaccharides made up of D-glucose monomers linked by β-type glycosidic bonds.

β-glucans have been previously described in bacteria, fungi, yeasts (including brewer's yeast), plants and algae, where they play an important structural role in the cell wall or reservoir.

There are more than 6000 β-glucans studies. At least 4 receptors have been identified in mammals for the recognition of these molecules: lactosylceramide, scavengers, complement receptor 3 and dectin-1.

Commercial production of 1,3-β-glucans has been carried out by cultivating bacteria, yeasts, fungi, and plants.

Recent studies focusing on their influence on cytotoxic and helper T cells, APCs, inflammatory pathways, and oxidative burst (using reactive oxygen species to kill cells) have revealed that they may also have some anti-cancer properties. Some efforts have been made in the field of cervical cancer prevention and it has been shown that β-glucans can also affect HPV infection. Carboxymethyl β-glucan gel treatment was studied in a group of affected individuals by CIN1. This case-control study demonstrated that it has an anti-cervical cancer role in CIN1 regression. In 2010, two studies were conducted on the topic of "the influence of β-glucans" on HPV-related lesions in the genital area. "The first study found that β-glucans can treat infection-related lesions and the second study revealed the efficacy of beta-glucan treatment for HPVCIN1 lesions. These studies suggested that, in addition to the anticancer effects of beta-glucans, they also have some effects on infection by HPV, the main cause of cervical cancer.

On the other hand, the local treatment of vaginal problems has been known since ancient times, and more recently it has been favored over oral treatments due to the achievement of higher local concentrations of drugs and fewer interactions of the active principles and interference with the gastrointestinal tract. Vaginal products are marketed in the form of tablets, capsules, pessaries or ovules and semisolid forms (creams, ointments and gels), being available as products for the treatment and prevention of vaginal infections. Conventional dosage forms are associated with poor distribution and retention, primarily due to the self-cleaning action of the vagina. Among the commercialized dosage forms, semisolids, in particular gels, have been considered the preferred ones as they spread easily over the vaginal surface area. Additionally, due to their high water content, they confer moisture and lubrication effects that help alleviate the symptoms of conditions associated with vaginal dryness.

Bioadhesion refers to the binding of natural or synthetic macromolecules to a biological tissue. Mucoadhesion is considered a particular case of bioadhesion whenever the binding occurs with mucous glycoproteins (mucin) or mucous membranes. The translation of these concepts into pharmaceutical technology has been widely studied through the use of bioadhesive polymers. Among the most used in vaginal formulations are polyacrylates (such as carbomers and polycarbophils), cellulose derivatives (hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), etc.), chitosan, hyaluronic acid and its derivatives, starch, pectin, natural gums and sodium alginate. In addition to increasing the retention time of vaginal formulations, thus promoting therapeutic duration and efficacy and improving patient comfort and adherence, these excipients also allow controlled drug release, thus improving local pharmacokinetics.

Polycarbophil and carbomer (polyacrylate) vaginal applications have been specially studied in vitro and in vivo, and have been included in various proprietary formulations as well as actual marketed products. These polymers have the additional advantage of being acidic, allowing the correction and maintenance of vaginal pH, and their acid-buffering capacity has been explored as a strategy for the treatment of bacterial vaginosis and the prevention of vaginosis recurrence for prevent the proliferation of pathogens, while promoting the restoration of the protective flora of Lactobacillus.

Polycarbophil, in particular, has been widely used for its bioadhesive properties, especially after a 1-3% polycarbophil gel was shown to maintain vaginal acidity for 3-4 days after a single application in postmenopausal women and A polycarbophil-carbomer vaginal gel was proven in women with suspected and confirmed bacterial vaginosis to show a reduction in vaginal pH in both trials, and a high clinical cure rate in confirmed vaginosis cases compared to placebo.

The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally on the regression of low-grade Cervical intraepithelial lesions (CIN) associated to HR-HPV infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz
        • Contact:
        • Principal Investigator:
          • Raquel Sanz Baró, MD
      • Madrid, Spain, 28041
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • María Serrano Velasco, MD
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
        • Contact:
          • Gonzalo Nozaleda, MD
        • Contact:
        • Principal Investigator:
          • Gonzalo Nozaleda
    • Madrid
      • Vallecas, Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jesús de la Fuente, MD
        • Principal Investigator:
          • Juan José Hernández Aguado, MD
        • Sub-Investigator:
          • Ester Martínez lamela, MD
        • Sub-Investigator:
          • Gema Aguion Gálvez, MD
        • Sub-Investigator:
          • Damián Sánchez Torres, MD
        • Sub-Investigator:
          • Almudena Pérez Quintanilla, MD
        • Sub-Investigator:
          • Eva Sanz Espinosa, MD
        • Sub-Investigator:
          • Jorge Muñoz Rodríguez, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman between 30 and 50 years old
  • Capable of understanding the Pacient Information Sheet and the Informed Consent form
  • Accepting her particpation in the study and signing the Informed Consent
  • LSIL/CIN1 hystological result on cervical biopsy preceeded by HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
  • Cervical cytology ≥ ASCUS or precceded by a HPV16+ test and negative cervical cytology for lesion or malignancy but with CIN1 colposcopy and biopsy.

Exclusion Criteria:

  • Cervical cytology suspicious of invasive cervical cancer
  • Current or previous pregnancy ended before six weeks in relation to the start of the study.
  • Vaccination against HPV.
  • Clinically relevant pathology linked to immunodeficiency.
  • Immunosuppressive treatment active or finished before six months in relation to the start of the study. In the specific case of corticosteroids, all women who are receiving corticosteroid treatment currently or recently (defined as the two weeks prior to the start of the study) or if she has received 2 or more cycles of corticosteroids in equal or greater than 20 mg / day of predsinone (or equivalent) orally or parenterally, for one week duration at least in the year prior to the start of the study. The use of inhaled corticosteroids, Nasal or topical are not exclusion criteria.
  • Undiagnosed abnormal genital bleeding.
  • Total hysterectomy.
  • Presence of genital warts and other symptomatic vulvovaginal infections.
  • Documented history of cervical pathology caused by HPV.
  • Current systemic and / or gynecological disease that contraindicates the use of Colpofix.
  • Contraindications to the use of Colpofix or known allergies to any of its components
  • Simultaneous participating in a clinical study of an investigational drug or that could interfere with the use of Colpofix.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No intervention (standard of care)
Experimental: Intervention (Colpofix)
Intravaginal gel with Carboxymethyl-β-glucan and Polycarbophil
Device: Colpofix
Intravaginal gel with carboxymtheyl beta-glucan and polycabophil. Posology: 1 application / day x 20 days, rest 10. Repeat 20 x 3 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in CIN1 regression rate
Time Frame: 24 months (6, 12, 18 and 24 months)
CIN evaluation by biopsy
24 months (6, 12, 18 and 24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CIN1 lesion regression or clearance time
Time Frame: 24 months (6, 12, 18 and 24 months)
CIN evaluation by biopsy
24 months (6, 12, 18 and 24 months)
Progression to CIN2+ rate
Time Frame: 24 months (6, 12, 18 and 24 months)
CIN evaluation by biopsy
24 months (6, 12, 18 and 24 months)
HPV clearance rate
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of HPV clearance time by HPV PCR test
24 months (6, 12, 18 and 24 months)
HPV clearance time
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of HPV clearance time by HPV PCR test
24 months (6, 12, 18 and 24 months)
Normalization rate of abnormal cytology
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of normal/abnormal cytologies
24 months (6, 12, 18 and 24 months)
Normalization time of abnormal cytology
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of normal/abnormal cytologies
24 months (6, 12, 18 and 24 months)
Normalization rate of abnormal colposcopy
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of normal/abnormal colposcopy
24 months (6, 12, 18 and 24 months)
Normalization time of abnormal colposcopy
Time Frame: 24 months (6, 12, 18 and 24 months)
Evaluation of normal/abnormal colposcopy
24 months (6, 12, 18 and 24 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uriach Consumer Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital General Universitario Gregorio Marañon
Hospital Universitario 12 de Octubre
Hospital Universitario Infanta Leonor
Hospital Universitario Fundación Jiménez Díaz
Hospital San Carlos, Madrid
Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan José Hernández Aguado, MD, Hospital Universitario Infanta Leonor

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLUCANCIN V3 22/9/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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