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| Name | Class |
|---|---|
| Adknoma Health Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - papilocare alternative days treatment | Experimental | 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) |
|
| B - papilocare semiintensive treatment | Experimental | 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) |
|
| C - papilocare intensive treatment | Experimental | Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months |
|
| D - standard of care | No Intervention | Arm D: usual clinical practice - no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papilocare vaginal gel | Device | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Cortes Bordoy, MD | AEPCC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital U. de Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain | ||
| Hospital Universitario HM Puerta del Sur |
The PIs from the participant sites gonna received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study has finished and the data has been analyzed, the PI's from the sites gonna received the CSR.
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| 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] |
| Móstoles |
| Madrid |
| 28938 |
| Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | Mallorca | 07120 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Complejo Hospitalario Torrecárdenas | Almería | 04009 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d' Hebron | Barcelona | 08035 | Spain |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| H. U. Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Assir Hospitalet de Llobregat | L'Hospitalet de Llobregat | 08904 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital de Manacor | Manacor | Spain |
| H. R. U. de Málaga / Materno Infantil | Málaga | 29010 | Spain |
| H. General Universitario Santa Lucía | Murcia | 30202 | Spain |
| Hospital Virgen de la Macarena | Seville | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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