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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
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
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.
Time frame: 6 months
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image at 3 and 12 months after the start of treatment.
Time frame: 3 and 12 months
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:\> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: \<25% and 5 is no ectopy).
Time frame: 3,6 and 12 months
Vaginal health status measured by Bachmann Index.
Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.
Time frame: 3,6 and 12 months
Satisfaction of papilocare gel use measured by likert scale.
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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
Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).
Time frame: 3 and 6 months
Therapeutic compliance
Evaluate the therapeutic compliance from the start of treatment
Time frame: 3 and 6 months