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

NCT04199260 | Completed

• 1 other identifier: PAPILOBS-2017-01
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 9

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.

Conditions

HPV Infection; Lesion Cervix

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage of patient who clear partially or completely the presence of HPV

  6 months

• Percentage of patient who clear partially or completely the presence of HPV

  12 months if applicable

• Patient's satisfaction degree with the study treatment

  6 months

• Patient's satisfaction degree with the study treatment

  12 months if applicable

• Safety and tolerability of treatment

  6 months

Other Outcomes (2)

• Evaluate the results of the biopsy (optional)

  6 months

• Evaluate the results of the biopsy (optional)

  12 months if applicable

Study Arms (1)

Papilocare

all patients gonna received papilocare treatment as per usual practice.

Device: papilocare vaginal gel

Interventions

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

Papilocare

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Woman over 25 years, whether or not they have been vaccinated against HPV.
• 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.
• 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®.
• Patient who, under that situation, undergoes a colposcopy and has a concordant result with cytology.
• Patient who has been prescribed treatment with Papilocare® by medical decision prior to their participation in the study.

You may not qualify if:

• Any situation / alteration / pathology, gynecological or not, which, in medical judgment, does not advise or contraindicate the use of Papilocare®.
• 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.
• Any planned surgery that precludes correct compliance with the guideline.
• Known allergies to any of the components of Papilocare®.

Sponsors & Collaborators

• Procare Health Iberia S.L.: lead
• Adknoma Health Research: collaborator

Study Sites (9)

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Women´s Health Institute

Barcelona, 08017, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Clínica Diatros

Barcelona, Spain

Location

Gabinete Médico Velázquez

Madrid, 28001, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, 41720, Spain

Location

MD Anderson

Madrid, Spain

Location

Hospital Quirón Málaga

Málaga, 29004, Spain

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: May 20, 2018
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

ES (9)