Investigation to Evaluate PAPILOCARE® Gel Effect on Normalization of Cervix Cytological Alterations Caused by HPV. (PAPILOBS)

• ClinicalTrials.gov Identifier: NCT04199260
• Recruitment Status: Completed
• First Posted: December 13, 2019
• Last Update Posted: August 9, 2021
• Sponsor: Procare Health Iberia S.L.
• Collaborator: Adknoma Health Research
• Information provided by (Responsible Party): Procare Health Iberia S.L.

Tracking Information

• First Submitted Date: December 11, 2019
• First Posted Date: December 13, 2019
• Last Update Posted Date: August 9, 2021
• Actual Study Start Date: May 20, 2018
• Actual Primary Completion Date: February 18, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 12, 2019)

• Percentage of patient who normalized their cytology with concordant colposcopy. [ Time Frame: 6 months ]
  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.
• Percentage of patient who normalized their cytology with concordant colposcopy. [ Time Frame: 12 months if applicable ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 12, 2019)

• Percentage of patient who clear partially or completely the presence of HPV [ Time Frame: 6 months ]
  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.
• Percentage of patient who clear partially or completely the presence of HPV [ Time Frame: 12 months if applicable ]
  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.
• Patient's satisfaction degree with the study treatment [ Time Frame: 6 months ]
  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.
• Patient's satisfaction degree with the study treatment [ Time Frame: 12 months if applicable ]
  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.
• Safety and tolerability of treatment [ Time Frame: 6 months ]
  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.
• Safety and tolerability of treatment [ Time Frame: 12 months if applicable ]
  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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: December 12, 2019)

• Evaluate the results of the biopsy (optional) [ Time Frame: 6 months ]
  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.
• Evaluate the results of the biopsy (optional) [ Time Frame: 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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Investigation to Evaluate PAPILOCARE® Gel Effect on Normalization of Cervix Cytological Alterations Caused by HPV.
• Official Title: Investigación clínica Para la evaluación Del Efecto de PAPILOCARE® en la normalización de Las Alteraciones citológicas Del Cuello Del útero Causadas Por el VPH
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Probability Sample

Study Population

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.

Condition

• HPV Infection
• Lesion Cervix

Intervention

Device: papilocare vaginal gel

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

Study Groups/Cohorts

Papilocare

all patients gonna received papilocare treatment as per usual practice.

Intervention: Device: papilocare vaginal gel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 6, 2021): 263
• Original Estimated Enrollment (submitted: December 12, 2019): 300
• Actual Study Completion Date: February 18, 2021
• Actual Primary Completion Date: February 18, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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®.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 25 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04199260
• Other Study ID Numbers: PAPILOBS-2017-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Procare Health Iberia S.L.
• Original Responsible Party: Same as current
• Current Study Sponsor: Procare Health Iberia S.L.
• Original Study Sponsor: Same as current
• Collaborators: Adknoma Health Research
• Investigators: Not Provided
• PRS Account: Procare Health Iberia S.L.
• Verification Date: August 2021