Clinical trial · Observational
Investigation to Evaluate PAPILOCARE® Gel Effect on Normalization of Cervix Cytological Alterations Caused by HPV.
Investigación clínica Para la evaluación Del Efecto de PAPILOCARE® en la normalización de Las Alteraciones citológicas Del Cuello Del útero Causadas Por el VPH
NCT04199260CI-TRIAL-00053166PAPILOBScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| Lesion Cervix | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| papilocare vaginal gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Papilocare
- description
- all patients gonna received papilocare treatment as per usual practice.
- interventionNames
- Device: papilocare vaginal gel
Primary outcomes (2)
- measure
- Percentage of patient who normalized their cytology with concordant colposcopy.
- timeFrame
- 6 months
- description
- 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.
- measure
- Percentage of patient who normalized their cytology with concordant colposcopy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: 1. Woman over 25 years, whether or not they have been vaccinated against HPV. 2. Able to read and understand the Patient Information Sheet and the Informed Consent form and accept the participation in the study by signing the Informed Consent form. 3. Patient who comes to a visit with a routine cytological result of ASCUS or LSIL and HPV-positive test, of at most 3 months prior to the start of treatment with Papilocare®. 4. Patient who, under that situation, undergoes a colposcopy and has a concordant result with cytology. 5. Patient who has been prescribed treatment with Papilocare® by medical decision prior to their participation in the study. Exclusion Criteria: 1. Any situation / alteration / pathology, gynecological or not, which, in medical judgment, does not advise or contraindicate the use of Papilocare®. 2. Women of childbearing age who do not use effective contraceptive methods, pregnant women, suspected pregnancy, desire for the same within the next 6 months or during breastfeeding. 3. Participation in any one clinical trial at present or in the 4 weeks prior to inclusion in the study. 4. Any planned surgery that precludes correct compliance with the guideline. 5. Known allergies to any of the components of Papilocare®.
References
Publications (0)
Data not yet available
No reference posted for this study.