Clinical trial · Interventional
Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil in HR-HPV Clearance
Evaluation of the Efficacy of an Intravaginal Treatment With Carboxymethyl-β-glucan and Polycarbophil in the Clearance of High-risk Human Papillomavirus Infection
NCT04781023CI-TRIAL-00052203GLUCANVIRunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colpofix | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention (Colpofix)
- description
- intravaginal gel with carboxymtheyl beta-glucan and polycabophil
- interventionNames
- Device: Colpofix
- type
- NO_INTERVENTION
- label
- Control
- description
- No intervention (standard of care)
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 24 months (6, 12, 18 and 24 months)
- description
- Evaluation of the change in HPV clearance by HPV PCR test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (7)
- BACKGROUNDGeller 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
- BACKGROUNDChaichian 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
- BACKGROUNDStentella 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
- BACKGROUNDPietrantoni 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
- BACKGROUNDScardamaglia 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
- BACKGROUNDPalmeira-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
- BACKGROUNDFiorilli 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.