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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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - papilocare alternative days | 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) |
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| B - papilocare semiintensive | 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 - standard of care | No Intervention | Arm C: 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 single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Cortés Bordoy, MD | Hospital os Palma de Mallorca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain | |||
| Clínica Diatros - TEKNON |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33743523 | Derived | 2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available. |
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It must be discussed with investigators team
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| 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). | 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. | 3,6 and 12 months |
| Satisfaction of papilocare gel use measured by likert scale. | 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). | 3 and 6 months |
| Therapeutic compliance | Evaluate the therapeutic compliance from the start of treatment | 3 and 6 months |
| Barcelona |
| 08017 |
| Spain |
| Women´s Health Institute | Barcelona | 08017 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Gabinete Médico Velázquez | Madrid | 28001 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Instituto Palacios de Salud y Medicina de la Mujer | Madrid | 41720 | Spain |
| Hospital Quirón Málaga | Málaga | 29004 | 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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