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

Investigación clínica Para la evaluación Del Efecto de PAPILOCARE® en la normalización de Las Alteraciones citológicas Del Cuello Del útero Causadas Por el VPH

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.

Study Overview

• Status: Completed
• Conditions: HPV Infection; Lesion Cervix
• Intervention / Treatment: Device: papilocare vaginal gel

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
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08017
    • Women´s Health Institute
  • Barcelona, Spain
    • Clínica Diatros
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • MD Anderson
  • Madrid, Spain, 28001
    • Gabinete Médico Velázquez
  • Madrid, Spain, 41720
    • Instituto Palacios de Salud y Medicina de la Mujer
  • Málaga, Spain, 29004
    • Hospital Quirón Málaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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®.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Papilocare; all patients gonna received papilocare treatment as per usual practice.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Procare Health Iberia S.L.
• Collaborators: Adknoma Health Research

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2018
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: PAPILOBS-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No