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) in 4 arms.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Papilocare is a gel vaginally administered by a singledose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
Hospital U. de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Evaluate the repairment of the cervico-vaginal mucosa in positive high risk 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
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Evaluate the repairment of the cervico-vaginal mucosa in positive high risk 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
Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale
A likert-type scale will be used to evaluate the reeptielization degree of the cervico-vaginal mucosa at 3, 6 and 12 months after the start of treatment.
Time frame: 3,6 and 12 months
Presence of HPV at 6 and 12 months after starting treatment.
Percentage of patients with total and partial clearance of HPV measured by genotyping PCR at 6 and 12 months after starting treatment.
Time frame: 6 and 12 months]
Evaluation of vaginal health status by vaginal health index score (Bachmann)
The vaginal health index score (Bachmann) will be used to evaluate vaginal health status at 3, 6 and 12 months from the start of treatment
Time frame: 3,6 and 12 months]
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Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Complejo Hospitalario Torrecárdenas
Almería, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
H. U. Reina Sofía
Córdoba, Spain
...and 9 more locations
To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.
Safety and tolerability: incidence, nature and severity of adverse events at 6 months of treatment and 6 months of follow-up period.
Time frame: 6 and 12 months]
To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.
The stress will be assessed on the PSS14 scale (Perceived Stress Scale 14 items) at 3, 6 and 12 months after the starting treatment.
Time frame: 3,6 and 12 months]
Evaluation of the satisfaction of papilocare gel use by a likert-type scale
A likert-type scale will be used to evaluate the satisfaction of papilocare gel use by the patients at 3 and 6 months after the start of treat
Time frame: 3 and 6 months]
Percentage of patients with good therapeutic compliance
Percentage of patients with good adherence to the treatment will be used to evaluate the therapeutic compliance at 3 and 6 months after the start of treatment.
Time frame: 3 and 6 months]