Human Papilloma Virus InfectionPALOMANCT04002154
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
A study testing Papilocare vaginal gel in people with Human Papilloma Virus Infection and Human Papilloma Virus, run by Procare Health Iberia S.L. at 9 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. All the patients included in the study will be Randomized (1:1:1). Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Human Papilloma Virus Infection, Human Papilloma Virus, 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
- 134 participants
- Where
- 9 sitesSpain
- Study dates
- 19 Oct 2015to 28 Feb 2019
- 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 included).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Accept participation in the study and sign the Informed Consent form.
- Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
- Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
- Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations 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 study.
- Any planned surgery that prevents the correct compliance with the protocol.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications for Papilocare gel use 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
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital General Universitario de Alicante
Alicante, 03010
Clínica Diatros - TEKNON
Barcelona, 08017
Women´s Health Institute
Barcelona, 08017
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Gabinete Médico Velázquez
Madrid, 28001
Hospital Infanta Leonor
Madrid, 28031
Hospital Clínico San Carlos
Madrid, 28040
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 41720
Hospital Quirón Málaga
Málaga, 29004
About this study
Official title: Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)
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. All the patients included in the study will be Randomized (1:1:1).
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. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (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.
- 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 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 |
|---|---|---|
| A - papilocare alternative days | 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 | 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 - standard of care | No intervention | Arm C: usual clinical practice: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive 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 (5)
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Evaluate the repairment of the cervico-vaginal mucosa in positive 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
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: <25% and 5 is no ectopy).
Measured: 3,6 and 12 months
Vaginal health status measured by Bachmann Index.
Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.
Measured: 3,6 and 12 months
Satisfaction of papilocare gel use measured by likert scale.
Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).
Measured: 3 and 6 months
Therapeutic compliance
Evaluate the therapeutic compliance from 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 posted28 Jun 2019
- Study start19 Oct 2015
- Primary completion31 Jul 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 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 Cortés Bordoy, MD, Study chair, Hospital os Palma de Mallorca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002154
- Sponsor's protocol ID
- PHPC-201501
- Acronym
- PALOMA
- Status last verified
- Feb 2021
- First submitted
- 21 Jun 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It must be discussed with investigators team
Publications
2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.
PubMed 33743523
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)
- ClinicalTrials.gov ID
- NCT04002154
- Acronym / sponsor ID
- PALOMA / PHPC-201501
- Keywords
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Collaborators
- Adknoma Health Research
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 28 Jun 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. All the patients included in the study will be Randomized (1:1:1).
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. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - papilocare alternative days | 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 | 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 - standard of care | No intervention | –Arm C: 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 included).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Accept participation in the study and sign the Informed Consent form.
- Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
- Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline 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 single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution | Device | A - papilocare alternative days, B - papilocare semiintensive |
Primary outcome
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Time frame: 6 months
Evaluate the repairment of the cervico-vaginal mucosa in positive 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.
5 secondary outcomes
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
Time frame: 3 and 12 months
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
Time frame: 3,6 and 12 months
Vaginal health status measured by Bachmann Index.
Time frame: 3,6 and 12 months
Satisfaction of papilocare gel use measured by likert scale.
Time frame: 3 and 6 months
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 16 Feb 2021.
- Derived from this study: PubMed 337435232021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.
- Individual participant dataSharing planned: Yes. It must be discussed with investigators team
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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 Cortés Bordoy, MD study chair
Hospital os Palma de Mallorca
9 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 Infection and Human Papilloma Virus, 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 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 16 Feb 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?
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy 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?
On the ClinicalTrials.gov record for NCT04002154, which also lists 1 linked publication.
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 16 Feb 2021.