Clinical trial NCT04199260: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Infection
Lesion Cervix
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
Collaborators: name: Adknoma Health Research
First posted: 2019-12-13
Enrollment: 263
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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®.

Primary outcomes:
measure: Percentage of patient who normalized their cytology with concordant colposcopy.
timeFrame: 6 months
measure: Percentage of patient who normalized their cytology with concordant colposcopy.
timeFrame: 12 months if applicable
Secondary outcomes:
measure: Percentage of patient who clear partially or completely the presence of HPV
timeFrame: 6 months
measure: Percentage of patient who clear partially or completely the presence of HPV
timeFrame: 12 months if applicable
measure: Patient's satisfaction degree with the study treatment
timeFrame: 6 months
measure: Patient's satisfaction degree with the study treatment
timeFrame: 12 months if applicable
measure: Safety and tolerability of treatment
timeFrame: 6 months
measure: Safety and tolerability of treatment
timeFrame: 12 months if applicable
Other outcomes:
measure: Evaluate the results of the biopsy (optional)
timeFrame: 6 months
measure: Evaluate the results of the biopsy (optional)
timeFrame: 12 months if applicable
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Women´s Health Institute
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Clínica Diatros
city: Madrid
country: Spain
facility: Gabinete Médico Velázquez
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Madrid
country: Spain
facility: MD Anderson
city: Málaga
country: Spain
facility: Hospital Quirón Málaga
Study officials:
References: