NCT06199128

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 533 (actual)
• Sponsor: Uriach Consumer Healthcare · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-22
• Primary completion: 2023-09-22
• Completion: 2023-11-22
• First posted: 2024-01-10
• Last updated: 2024-01-10

Locations

5 sites across 1 country: Spain