HPV InfectionPAPILOBSNCT04199260
Investigation to Evaluate PAPILOCARE® Gel Effect on Normalization of Cervix Cytological Alterations Caused by HPV.
An observational study of HPV Infection and Lesion Cervix, run by Procare Health Iberia S.L. at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- HPV Infection, Lesion Cervix
- What is being tested?
- papilocare vaginal gel
- Type of treatment
- Medical device
- How many people
- 263 participants
- Where
- 9 sitesSpain
- Study dates
- 20 May 2018to 18 Feb 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Participation in any one clinical trial at present or in the 4 weeks prior to inclusion in the study.
- Any planned surgery that precludes correct compliance with the guideline.
- Known allergies to any of the components of Papilocare®.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital General Universitario de Alicante
Alicante, 03010
Women´s Health Institute
Barcelona, 08017
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Clínica Diatros
Barcelona
Gabinete Médico Velázquez
Madrid, 28001
Hospital Clínico San Carlos
Madrid, 28040
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 41720
MD Anderson
Madrid
Hospital Quirón Málaga
Málaga, 29004
About this study
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
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.
Read the 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.
- Conditions
- HPV Infection, Lesion Cervix
- Being tested
- papilocare vaginal gel
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papilocare vaginal gelDevice
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 group | Role | What they receive |
|---|---|---|
| Papilocare | all patients gonna received papilocare treatment as per usual practice. Receives: Device: papilocare vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months if applicable
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 May 2018
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199260
- Sponsor's protocol ID
- PAPILOBS-2017-01
- Acronym
- PAPILOBS
- Status last verified
- Aug 2021
- First submitted
- 11 Dec 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04199260
- Acronym / sponsor ID
- PAPILOBS / PAPILOBS-2017-01
- Conditions
- HPV Infection, Lesion Cervix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Study start
- 20 May 2018 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Papilocare | – | Device: papilocare vaginal gelall patients gonna received papilocare treatment as per usual practice. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Participation in any one clinical trial at present or in the 4 weeks prior to inclusion in the study.
- Any planned surgery that precludes correct compliance with the guideline.
- Known allergies to any of the components of Papilocare®.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| papilocare vaginal gelPapilocare 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 | Device | Papilocare |
Primary outcome
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.
6 secondary outcomes
Percentage of patient who clear partially or completely the presence of HPV
Time frame: 6 months
Percentage of patient who clear partially or completely the presence of HPV
Time frame: 12 months if applicable
Patient's satisfaction degree with the study treatment
Time frame: 6 months
Patient's satisfaction degree with the study treatment
Time frame: 12 months if applicable
Safety and tolerability of treatment
Time frame: 6 months
Safety and tolerability of treatment
Time frame: 12 months if applicable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and Lesion Cervix, run by Procare Health Iberia S.L. at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient who normalized their cytology with concordant colposcopy. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.