Ignite Creation Date:
2025-12-18 @ 9:37 AM
Ignite Modification Date:
2025-12-23 @ 10:22 PM
Study NCT ID:
NCT04199078
Status:
None
Last Update Posted:
2024-10-31 00:00:00
First Post:
2019-12-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Sponsor:
None
Organization:
Study Overview
Official Title:
Ensayo clínico Aleatorizado, Abierto, Paralelo, Controlado, multicéntrico, Para Explorar la Eficacia Del Gel Vaginal Papilocare® en la reparación de la Mucosa Cervical Con Lesiones Causadas Por Virus Papiloma Humano de Alto Riesgo
Status:
None
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALOMA2
Brief 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-HR. All the patients included in the study will be randomized (1:1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (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. Total study duration: 13 months.
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. Total study duration: 13 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: