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Spots Global Cancer Trial Database for Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV

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Trial Identification

Brief Title: Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV

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)

Study ID: NCT04002154

Study Description

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. All the patients included in the study will be Randomized (1:1:1).

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. 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.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Hospital General Universitario de Alicante, Alicante, , Spain

Clínica Diatros - TEKNON, Barcelona, , Spain

Women´s Health Institute, Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Gabinete Médico Velázquez, Madrid, , Spain

Hospital Infanta Leonor, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Instituto Palacios de Salud y Medicina de la Mujer, Madrid, , Spain

Hospital Quirón Málaga, Málaga, , Spain

Contact Details

Name: Javier Cortés Bordoy, MD

Affiliation: Hospital os Palma de Mallorca

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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