Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Adknoma Health Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Observational clinical study, national, multicentric, prospective, non-comparative, with medical device, under application consistent with CE marking, for the evaluation of Papilocare® effectivness in the normalization of cervix cytological abnormalities caused by HPV.
300 patients will be included in approximately 50 Spanish sites. The study comprehend a maximum of 3 visits. At visit 1, patient's writted informed consent will be collected, patient's selection critera will be checked, and patient's medial history data will be collected. At visit 2, 6 months after the first visit, the primary and secondary objectives will be evaluated. For those patients who finish treatment after 6 months, this will be the final visit. Only in that cases where, by usual clinical practice, the doctor indicates patient should continue under treatment, visit 3, wich will take place 12 months after streatment stars, will be the last visit for the patient under study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Papilocare | all patients gonna received papilocare treatment as per usual practice. |
|
| 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 |
|---|---|---|
| Percentage of patient who normalized their cytology with concordant colposcopy. | The percentage of patients with normalization of the cytology with concordant colposcopy, at 6 months, and at 12 months if applicable, has been established as the main variable of the study, in order to assess the degree of normalization of cytological alterations. Colposcopy concordant with normalized cytology results will be considered those colposcopic findings classified as normal, non-specific or as abnormal grade 1 (minor) according to the definition of the Nomenclature Committee of the International Federation of Cervical and Colposcopic Pathology (IFCPC). accepted at the Rio World Congress, July 5, 2011. | 6 months |
| Percentage of patient who normalized their cytology with concordant colposcopy. | The percentage of patients with normalization of the cytology with concordant colposcopy, at 6 months, and at 12 months if applicable, has been established as the main variable of the study, in order to assess the degree of normalization of cytological alterations. Colposcopy concordant with normalized cytology results will be considered those colposcopic findings classified as normal, non-specific or as abnormal grade 1 (minor) according to the definition of the Nomenclature Committee of the International Federation of Cervical and Colposcopic Pathology (IFCPC). accepted at the Rio World Congress, July 5, 2011. | 12 months if applicable |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patient who clear partially or completely the presence of HPV | To evaluate the clearance of HPV, the percentage of patients with total or partial clearance of HPV measured by PCR or genetic diagnostic kits that allow the identification of strains at 6 months (and 12 months if applicable) from the start of treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the results of the biopsy (optional) | To assess the effect on biopsies (when available), the percentage of patients who improve and those who maintain the degree of histological alteration have been established at 6 months (and at 12 months if applicable) of the start of treatment. | 6 months |
| Evaluate the results of the biopsy (optional) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The main objective of the study is to evaluate the degree of normalization of cytological abnormalities of the cervix caused by HPV. For this purpose, women over 25 years old with positive HPV with lesions in the cervical mucosa, and concordant colposcopic image have been chosen as the target population.
No exceptional measures are planned for the recruitment of patients in this study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain | |||
| Women´s Health Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 23, 2023 | |
| Unrelease | May 23, 2023 | |
| Release | Nov 6, 2024 | |
| Reset | Dec 26, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 23, 2023 | May 23, 2023 | |||
| Nov 6, 2024 |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of patient who clear partially or completely the presence of HPV |
To evaluate the clearance of HPV, the percentage of patients with total or partial clearance of HPV measured by PCR or genetic diagnostic kits that allow the identification of strains at 6 months (and 12 months if applicable) from the start of treatment. |
| 12 months if applicable |
| Patient's satisfaction degree with the study treatment | Changes appreciated in the Likert scale at 6 months (and at 12 months if applicable) of the start of treatment will be used to evaluate satisfaction degree with the use of Papilocare gel as treatment. | 6 months |
| Patient's satisfaction degree with the study treatment | Changes appreciated in the Likert scale at 6 months (and at 12 months if applicable) of the start of treatment will be used to evaluate satisfaction degree with the use of Papilocare gel as treatment. | 12 months if applicable |
| Safety and tolerability of treatment | The incidence, nature and severity of adverse events during the 6 months (or 12 months if applicable) of the duration of the treatment will be used to assess the safety and tolerability of treatment. | 6 months |
| Safety and tolerability of treatment | The incidence, nature and severity of adverse events during the 6 months (or 12 months if applicable) of the duration of the treatment will be used to assess the safety and tolerability of treatment. | 12 months if applicable |
To assess the effect on biopsies (when available), the percentage of patients who improve and those who maintain the degree of histological alteration have been established at 6 months (and at 12 months if applicable) of the start of treatment. |
| 12 months if applicable |
| Barcelona |
| 08017 |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Clínica Diatros | Barcelona | Spain |
| Gabinete Médico Velázquez | Madrid | 28001 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Instituto Palacios de Salud y Medicina de la Mujer | Madrid | 41720 | Spain |
| MD Anderson | Madrid | Spain |
| Hospital Quirón Málaga | Málaga | 29004 | Spain |
| Dec 26, 2024 |
| 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 |