Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil in HR-HPV Clearance

NCT04781023 | Unknown DMC

• 1 other identifier: GLUCANVIR V1 15/7/2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

These treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV infection. The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally regarding the clearance of HPV infection.

Conditions

Human Papilloma Virus

Keywords

Human Papilomavirus; Cervical cancer; Cervial lesions; High-Risk Papillomavirus; beta-glucans

Outcome Measures

Primary Outcomes (1)

• Change in the clearance of high-risk HPV infection in women without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophilon the clearance of high-risk HPV infection in women without cytological alterations.

  Evaluation of the change in HPV clearance by HPV PCR test

  24 months (6, 12, 18 and 24 months)

Secondary Outcomes (5)

• Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the clearance rate of HPV

  24 months (6, 12, 18 and 24 months)

• Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the clearance time of HPV

  24 months (6, 12, 18 and 24 months)

• Change on the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time

  24 months (6, 12, 18 and 24 months)

• Safety assessment: incidence of Adverse Events

  24 months

• Tolerance assessment: measurement of treatment acceptance by subjects

  24 months

Study Arms (2)

Intervention (Colpofix)

EXPERIMENTAL

intravaginal gel with carboxymtheyl beta-glucan and polycabophil

Device: Colpofix

Control

NO INTERVENTION

No intervention (standard of care)

Interventions

Colpofix DEVICE

Intravaginal gel with carboxymtheyl beta-glucan and polycabophil. Posology: 1 application / day x 20 days, rest 10. Repeat 20 x 3 cycles

Intervention (Colpofix)

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sexually active women
• between 30 and 40 years old
• HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
• normal cytology

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Uriach Consumer Healthcare: lead
• Hospital Universitario Infanta Leonor: collaborator

Study Sites (1)

Hospital Universitario Infanta Leonor

Vallecas, Madrid, 28031, Spain

Location

Related Publications (7)

• Geller A, Shrestha R, Yan J. Yeast-Derived beta-Glucan in Cancer: Novel Uses of a Traditional Therapeutic. Int J Mol Sci. 2019 Jul 24;20(15):3618. doi: 10.3390/ijms20153618.

  PMID: 31344853 BACKGROUND

• Chaichian S, Moazzami B, Sadoughi F, Haddad Kashani H, Zaroudi M, Asemi Z. Functional activities of beta-glucans in the prevention or treatment of cervical cancer. J Ovarian Res. 2020 Mar 5;13(1):24. doi: 10.1186/s13048-020-00626-7.

  PMID: 32138756 BACKGROUND

• Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9.

  PMID: 28675291 BACKGROUND

• Pietrantoni E, Signore F, Berardi G, Donadio F, Donadio C. [Role of beta-glucan in the treatment of recurrent candidiasis and HPV-correlated lesions and reparative process of epidermis]. Minerva Ginecol. 2010 Feb;62(1):1-5. Italian.

  PMID: 20186110 BACKGROUND

• Scardamaglia P, Carraro C, Mancino P, Stentella P. [Effectiveness of the treatment with beta-glucan in the HPV-CIN 1 lesions]. Minerva Ginecol. 2010 Oct;62(5):389-93. Italian.

  PMID: 20938424 BACKGROUND

• Palmeira-de-Oliveira R, Palmeira-de-Oliveira A, Martinez-de-Oliveira J. New strategies for local treatment of vaginal infections. Adv Drug Deliv Rev. 2015 Sep 15;92:105-22. doi: 10.1016/j.addr.2015.06.008. Epub 2015 Jul 2.

  PMID: 26144995 BACKGROUND

• Fiorilli A, Molteni B, Milani M. Successful treatment of bacterial vaginosis with a policarbophil-carbopol acidic vaginal gel: results from a randomised double-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2005 Jun 1;120(2):202-5. doi: 10.1016/j.ejogrb.2004.10.011.

  PMID: 15925053 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jesús de la Fuente Valero, MD

  Hospital Universitario Infanta Leonor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus de la Fuente Valero, MD

CONTACT

+34669264966; jesus.fuente@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, longitudinal, prospective, open label trial with a control group with randomized, consecutive recruitment for each group, to evaluate the safety and efficacy of carboxymethyl-beta-glucan and polycarbophil as a treatment for high-risk HPV infection in women without cytological alterations.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 4, 2021
• Study Start: June 15, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)