Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Human Papilloma Virus, Human Papilloma Virus Infection, Cervix Lesion

Intervention / Treatment
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* Device: Papilocare vaginal gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman between the ages of 30 and 65 (both inclusive). Able to read and understand the Patient Information Sheet and the Informed Consent form. Acceptance in the participation of the essay and signature of the Informed Consent form. ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit). High risk HPV positive by PCR performed at screening visit. Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments throughout it. Exclusion Criteria: Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit). To had been vaccinated against HPV. Other symptomatic vulvovaginal infections. Surgical cervical excision in the last year or total hysterectomy. Previous history of gynecological cancer. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial. Any planned surgery that prevents the correct compliance with the guidelines. Use of vaginal contraceptives or other vaginal hormonal treatments. Contraindications for the use of Papilocare® gel or known allergies to any of its components. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - papilocare alternative days treatment<br>Arm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days) | Device: Papilocare vaginal gel<br>* 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<br>|
| Experimental: B - papilocare semiintensive treatment<br>Arm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days) | Device: Papilocare vaginal gel<br>* 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<br>|
| Experimental: C - papilocare intensive treatment<br>Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months | Device: Papilocare vaginal gel<br>* 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<br>|
| No Intervention: D - standard of care<br>Arm D: usual clinical practice - no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 3,6 and 12 months] | 
| 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. | 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. | 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 | 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. | 3 and 6 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV