Human Papilloma VirusPALOMA2NCT04199078
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
A study testing Papilocare vaginal gel in people with Human Papilloma Virus and Human Papilloma Virus Infection, run by Procare Health Iberia S.L. at 19 sites in Spain.
Trial summary
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Human Papilloma Virus, Human Papilloma Virus Infection, Cervix Lesion
- What is being tested?
- Papilocare vaginal gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 19 sitesSpain
- Study dates
- 25 Sep 2019to 30 Jun 2024
- Phase
- Interventional
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman between the ages of 30 and 65 (both inclusive).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Acceptance in the participation of the essay and signature of the Informed Consent form.
- ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
- High risk HPV positive by PCR performed at screening visit.
- Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments throughout it.
Who cannot join
- Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
- Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
- To had been vaccinated against HPV.
- Other symptomatic vulvovaginal infections.
- Surgical cervical excision in the last year or total hysterectomy.
- Previous history of gynecological cancer.
Show all 11Show fewer
- Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial.
- Any planned surgery that prevents the correct compliance with the guidelines.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications for the use of Papilocare® gel or known allergies to any of its components.
- Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital General Universitario de Alicante
Alicante, 03010
Complejo Hospitalario Torrecárdenas
Almería, 04009
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d' Hebron
Barcelona, 08035
Hospital de Basurto
Bilbao, 48013
H. U. Reina Sofía
Córdoba, 14004
Hospital U. de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Universitario Virgen de las Nieves
Granada, 18014
Assir Hospitalet de Llobregat
L'Hospitalet de Llobregat, 08904
Hospital Universitario La Paz
Madrid, 28046
H. R. U. de Málaga / Materno Infantil
Málaga, 29010
Hospital de Manacor
Manacor
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, 28938
H. General Universitario Santa Lucía
Murcia, 30202
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, 07120
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Virgen de la Macarena
Seville, 41009
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Álvaro Cunqueiro
Vigo, 36312
About this study
Official title: Ensayo clínico Aleatorizado, Abierto, Paralelo, Controlado, multicéntrico, Para Explorar la Eficacia Del Gel Vaginal Papilocare® en la reparación de la Mucosa Cervical Con Lesiones Causadas Por Virus Papiloma Humano de Alto Riesgo
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.
Read the detailed description
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (usual clinical practice-without treatment-).
Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment.
Patients will visit the site into a total of 5 visits throughout the study. Total study duration: 13 months.
- Being tested
- Papilocare vaginal gel
- Keywords
- HPV
- 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 singledose 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 |
|---|---|---|
| A - papilocare alternative days treatment | Experimental | Arm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days) Receives: Device: Papilocare vaginal gel |
| B - papilocare semiintensive treatment | Experimental | Arm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days) Receives: Device: Papilocare vaginal gel |
| C - papilocare intensive treatment | Experimental | Arm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months Receives: Device: Papilocare vaginal gel |
| D - standard of care | No intervention | Arm D: usual clinical practice - no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Evaluate the repairment of the cervico-vaginal mucosa in positive high risk HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.
Measured: 6 months
Secondary outcomes (8)
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Evaluate the repairment of the cervico-vaginal mucosa in positive high risk HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image at 3 and 12 months after the start of treatment.
Measured: 3 and 12 months
Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale
A likert-type scale will be used to evaluate the reeptielization degree of the cervico-vaginal mucosa at 3, 6 and 12 months after the start of treatment.
Measured: 3,6 and 12 months
Presence of HPV at 6 and 12 months after starting treatment.
Percentage of patients with total and partial clearance of HPV measured by genotyping PCR at 6 and 12 months after starting treatment.
Measured: 6 and 12 months]
Evaluation of vaginal health status by vaginal health index score (Bachmann)
The vaginal health index score (Bachmann) will be used to evaluate vaginal health status at 3, 6 and 12 months from the start of treatment
Measured: 3,6 and 12 months]
To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.
Safety and tolerability: incidence, nature and severity of adverse events at 6 months of treatment and 6 months of follow-up period.
Measured: 6 and 12 months]
To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.
The stress will be assessed on the PSS14 scale (Perceived Stress Scale 14 items) at 3, 6 and 12 months after the starting treatment.
Measured: 3,6 and 12 months]
Evaluation of the satisfaction of papilocare gel use by a likert-type scale
A likert-type scale will be used to evaluate the satisfaction of papilocare gel use by the patients at 3 and 6 months after the start of treat
Measured: 3 and 6 months]
Percentage of patients with good therapeutic compliance
Percentage of patients with good adherence to the treatment will be used to evaluate the therapeutic compliance at 3 and 6 months after the start of treatment.
Measured: 3 and 6 months]
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 start25 Sep 2019
- Primary completion31 Jan 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Responsible party
- Sponsor
- Investigators
- Javier Cortes Bordoy, MD, Study chair, AEPCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199078
- Sponsor's protocol ID
- PALOMA II
- Acronym
- PALOMA2
- Status last verified
- Oct 2024
- First submitted
- 11 Dec 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PIs from the participant sites gonna received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study has finished and the data has been analyzed, the PI's from the sites gonna received the CSR.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo clínico Aleatorizado, Abierto, Paralelo, Controlado, multicéntrico, Para Explorar la Eficacia Del Gel Vaginal Papilocare® en la reparación de la Mucosa Cervical Con Lesiones Causadas Por Virus Papiloma Humano de Alto Riesgo
- ClinicalTrials.gov ID
- NCT04199078
- Acronym / sponsor ID
- PALOMA2 / PALOMA II
- Keywords
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Jun 2024 (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.
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.
Detailed description
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (usual clinical practice-without treatment-).
Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment.
Patients will visit the site into a total of 5 visits throughout the study. Total study duration: 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - papilocare alternative days treatment | Experimental | Device: Papilocare vaginal gelArm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days) |
| B - papilocare semiintensive treatment | Experimental | Device: Papilocare vaginal gelArm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days) |
| C - papilocare intensive treatment | Experimental | Device: Papilocare vaginal gelArm C: scheme C (21 days / 1 cannula per day + 7 days rest) x 6 months |
| D - standard of care | No intervention | –Arm D: usual clinical practice - no treatment |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman between the ages of 30 and 65 (both inclusive).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Acceptance in the participation of the essay and signature of the Informed Consent form.
- ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
- High risk HPV positive by PCR performed at screening visit.
Key exclusion criteria (11 listed)
- Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
- Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
- To had been vaccinated against HPV.
- Other symptomatic vulvovaginal infections.
- Surgical cervical excision in the last year or total hysterectomy.
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 singledose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution | Device | A - papilocare alternative days treatment, B - papilocare semiintensive treatment, C - papilocare intensive treatment |
Primary outcome
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Time frame: 6 months
Evaluate the repairment of the cervico-vaginal mucosa in positive high risk HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.
8 secondary outcomes
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image
Time frame: 3 and 12 months
Evaluation of reeptielization degree of the cervico-vaginal mucosa by a likert-type scale
Time frame: 3,6 and 12 months
Presence of HPV at 6 and 12 months after starting treatment.
Time frame: 6 and 12 months]
Evaluation of vaginal health status by vaginal health index score (Bachmann)
Time frame: 3,6 and 12 months]
To evaluate the safety and tolerability of Papilocare® gel during the 6 months of treatment and 6 months of follow-up.
Time frame: 6 and 12 months]
To assess the stress received from the patients at 3, 6 and 12 months after starting treatment.
Time frame: 3,6 and 12 months]
Evaluation of the satisfaction of papilocare gel use by a likert-type scale
Time frame: 3 and 6 months]
Percentage of patients with good therapeutic compliance
Time frame: 3 and 6 months]
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. The PIs from the participant sites gonna received the study protocol and the informed consent form previously to the initiation of the study and every time it occurs an amendment over the protocol, ICF or any other study document. Once the study has finished and the data has been analyzed, the PI's from the sites gonna received the CSR.
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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.
Javier Cortes Bordoy, MD study chair
AEPCC
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papilocare vaginal gel in people with Human Papilloma Virus and Human Papilloma Virus Infection, run by Procare Health Iberia S.L. at 19 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 6 inclusion and 11 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image (time frame: 6 months). 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 2 Sep 2026.