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

Human Papillomavirus Infection Clinical Trial

— Fix  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199128
• Other study ID #: The Fix Study V.2 12/Jul/2022
• Status: Completed
• Start date: September 22, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: December 2023
• Source: Uriach Consumer Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: November 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Dietary Supplement:
• carboxymethyl ß-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

Locations

Country	Name	City	State
Spain	Hospital CIMA, Barcelona	Barcelona
Spain	Hospital Quirón San José	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario Infanta Leonor,	Madrid
Spain	Hospital Quirón Donostia	San Sebastián

Sponsors (1)

Lead Sponsor	Collaborator
Uriach Consumer Healthcare

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

Jentschke M, Lehmann R, Drews N, Hansel A, Schmitz M, Hillemanns P. Psychological distress in cervical cancer screening: results from a German online survey. Arch Gynecol Obstet. 2020 Sep;302(3):699-705. doi: 10.1007/s00404-020-05661-9. Epub 2020 Jun 27. — View Citation

Laccetta G, Carrone A, Burratti M, Mancino P. Effect of the treatment with beta-glucan in women with cervical cytologic report of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). Minerva Ginecol. 2015 Apr;67(2):113-20. Epub 2015 Feb 5. — View Citation

Lavitola G, Della Corte L, De Rosa N, Nappi C, Bifulco G. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. Biomed Res Int. 2020 Apr 27;2020:5476389. doi: 10.1155/2020/5476389. eCollection 2020. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-ß-glucan and polycarbophil.	Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype	6 months
Secondary	Normalization rate of abnormal colposcopy	Evaluation of abnormal or normal colposcopy	6 Months
Secondary	Change in the incidence of cytological alterations upon local treatment with carboxymethyl - ß-glucan and polycarbophil during the follow-up time	Change in the incidence of cytological alterations development measured by reflex cytology test (Normal Cytology; ASCUS; LSIL or HSIL cytology)	6 Months
Secondary	Determine the effect of local treatment with carboxymethyl - ß-glucan and polycarbophil on the total negativization rate of HPV	Evaluation of HPV total negativization rate by HPV PCR test with genotype	6 Months