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

Completed

• Conditions: Lesion Cervix; HPV Infection
• Interventions: Device: papilocare vaginal gel

• Registration Number: NCT04199260
• Lead Sponsor: Procare Health Iberia S.L.

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 Timeline

• Study Start: 2018-05-20
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Primary Completion: 2021-02-18
• Study Completion: 2021-02-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 263

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Papilocare	papilocare vaginal gel	all patients gonna received papilocare treatment as per usual practice.

Primary Outcome Measures

Name	Time	Method
Percentage of patient who normalized their cytology with concordant colposcopy.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of patient who clear partially or completely the presence of HPV	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	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	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.

Trial Locations

Locations (9)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Clínica Diatros; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Women´s Health Institute; 🇪🇸 Barcelona, Spain

Instituto Palacios de Salud y Medicina de la Mujer; 🇪🇸 Madrid, Spain

Gabinete Médico Velázquez; 🇪🇸 Madrid, Spain

Hospital Quirón Málaga; 🇪🇸 Málaga, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

MD Anderson; 🇪🇸 Madrid, Spain