Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV — PALOMA  

Human Papilloma Virus Clinical Trial

Official title: Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)

Status Completed

Clinical Trial Summary

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).

Clinical Trial Description

Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual clinical practice -without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study. ;

Related Conditions & MeSH terms

• Cervix Lesion
• Human Papilloma Virus
• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

• NCT number: NCT04002154
• Study type: Interventional
• Source: Procare Health Iberia S.L.
• Status: Completed
• Phase: N/A
• Start date: October 19, 2015
• Completion date: February 28, 2019