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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
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.
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Javier Cortés Bordoy, MD
Affiliation: Hospital os Palma de Mallorca
Role: STUDY_CHAIR