Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04199078
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2019-12-11
Brief Title:
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions
Sponsor:
Procare Health Iberia SL
Organization:
Procare Health Iberia SL
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 1111 in 4 arms
Detailed 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-HR All the patients included in the study will be randomized 1111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None