HPV InfectionPAPILOCANNCT04210336
Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV
A study testing PAPILOCARE and LACTIC ACID GEL in people with HPV Infection and Lesion Cervix, run by Procare Health Iberia S.L. at 1 site in Spain.
Trial summary
Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV. The study is divided into two parts. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV Infection, Lesion Cervix
- What is being tested?
- PAPILOCARE and LACTIC ACID GEL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2018to 20 Jan 2023
- 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 informed consent
- Accept participation in the study and sign the Informed Consent.
- Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
- Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
- Women vaccinated and not vaccinated against HPV.
- Is able, at the discretion of the researcher, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout it.
Who cannot join
- Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
- Other cytological results other than those provided for in the inclusion criteria.
- Baseline LSIL biopsies with CIN-3.
- Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
- Other symptomatic vulvovaginal infections.
- Surgical cervical excision in the last year or total hysterectomy.
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- Previous history of gynecological cancer.
- Participation in any other clinical trial at present or in the 4 weeks prior to inclusion of the study.
- Any planned surgery that precludes correct compliance with the guideline.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications to 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 suspected pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
About this study
Official title: Estudio clínico, Aleatorizado, Doble Ciego, Paralelo, Controlado Con Gel de ácido láctico Para Evaluar la Eficacia Del Gel Papilocare® en la reparación de Lesiones Cervicales Causadas Por VPH. A Randomized, Double-blind, Parallel-group, Controlled Clinical Trial Using Lactic Acid Gel to Evaluate the Efficacy of Papilocare® Gel in Repairing Cervical Lesions Caused by HPV.
Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
Read the detailed description
Phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
The study is divided into 2 parts, the first 100 randomized patients will receive treatment with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on alternate days for 5 months (except for menstruation days). The second part of the study, randomized patients from position 101 to 200, will receive treatment with an administration regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months (except the days of menstruation).
Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit, V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).
- Conditions
- HPV Infection, Lesion Cervix
- Being tested
- PAPILOCARE, LACTIC ACID 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.
PAPILOCAREDevice
Papilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa.
Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera.
LACTIC ACID GELDevice
The lactic acid gel consists of a carrier gel with the absence of the active ingredients of Papilocare®.
| Study group | Role | What they receive |
|---|---|---|
| PAPILOCARE | Experimental | Randomized patients will receive two different guidelines depending on the time of randomization:
* Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
* Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) . Receives: Device: PAPILOCARE |
| LACTIC ACID GEL | Active comparator | Randomized patients will receive two different guidelines depending on the time of randomization:
* Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ).
* Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) . Receives: Device: LACTIC ACID GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical mucosal repair
Percentage of patients with cervical lesions negativization confirmed be cytology and accordance colposcopy , at 6 months will be used to evaluate the main variables, degree of cervical mucosal repair in HPV-positive women with ASC-US or LSIL.
Measured: 6 months
Secondary outcomes (6)
Reepithelialization degree of the cervical mucosa
Percentage of patients with negativity of cervical lesions by cytology and accordance colposcopy, at 3 months
Measured: at 3 months
Percentage of patients with Viral clearance
Percentage of patients with initial HPV clearance measured by PCR at 3 and 6 months.
Measured: 3 and 6 months.
Vaginal health status measured by vaginal health index (VHI)
Changes in the VHI (vaginal health index -Bachmann) at 3 and 6 months.
VHI was developed in order to objectively assess female urogenital health (Bachmann GMaturitas. 1995 Dec; 22 Suppl():S1-S5.). This test evaluates overall elasticity, fluid secretion type and consistency, vaginal pH, epithelial mucosa and moisture. Minimum score is 5 and maximum is 25. Lower scores corresponds to greater urogenital atrophy.
Measured: 3 and 6 months.
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
Changes PSS-14 scale (Perceived Stress Scale 14 items) at 3 and 6 months.
The PSS-14 is comprised of 14 items, score ranges from 0-56, with higher scores indicating greater perceived stress
Measured: 3 and 6 months.
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Record of the incidence, nature and severity of adverse events: during the 6 months of treatment duration.
Measured: 6 months
Satisfaction degree with Papilocare gel use: Likert type scale
Patients satisfaction degree with papilocare gel use as treatment will be evaluated by a likert type scale.
A Likert scale is a psychometric scale commonly involved in research that employs questionnaires. It is the most widely used approach to scaling responses in survey research.Likert scaling assumes distances between each choice (answer option) are equal. Higher scores corresponds to better satisfaction with papilocare gel use.
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 posted24 Dec 2019
- Study start7 Aug 2018
- Primary completion30 Nov 2022
- Study completion20 Jan 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procare Health Iberia S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfonso Quesada López-Fe, Doctor, Principal investigator, H Nuestra Señora de la Candelaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210336
- Sponsor's protocol ID
- PAPILOCAN
- Acronym
- PAPILOCAN
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI from the participant site 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 will finish and the data will be analyzed, the PI will receive the CSR.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio clínico, Aleatorizado, Doble Ciego, Paralelo, Controlado Con Gel de ácido láctico Para Evaluar la Eficacia Del Gel Papilocare® en la reparación de Lesiones Cervicales Causadas Por VPH. A Randomized, Double-blind, Parallel-group, Controlled Clinical Trial Using Lactic Acid Gel to Evaluate the Efficacy of Papilocare® Gel in Repairing Cervical Lesions Caused by HPV.
- ClinicalTrials.gov ID
- NCT04210336
- Acronym / sponsor ID
- PAPILOCAN / PAPILOCAN
- Conditions
- HPV Infection, Lesion Cervix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Procare Health Iberia S.L.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 24 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.
Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
Detailed description
Phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel clinical trial to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
The study is divided into 2 parts, the first 100 randomized patients will receive treatment with an administration regimen in both arms: 1 cannula / day for 1 month + 1 cannula on alternate days for 5 months (except for menstruation days). The second part of the study, randomized patients from position 101 to 200, will receive treatment with an administration regimen in both arms: 1 cannula / day for 3 months + 1 cannula on alternate days for 3 months (except the days of menstruation).
Duration of treatment: 6 months Total study duration: 13 months in 5 visits: selection visit, V0 or randomization visit (30 days), V1(Month 3), V2 (Month 6), V3 (Month 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAPILOCARE | Experimental | Device: PAPILOCARERandomized patients will receive two different guidelines depending on the time of randomization: * Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ). * Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) . |
| LACTIC ACID GEL | Active comparator | Device: LACTIC ACID GELRandomized patients will receive two different guidelines depending on the time of randomization: * Guideline A (from patient 1 to 100 in order of randomization): guideline of 1 cannula per day x 21 days + 7 days rest during the 1st month + 1 cannula / alternate days until completing 6 months (except for menstruation days ). * Guideline B (from patient 101 to 200 in order of randomization): pattern of 1 cannula per day x 21 days + 7 days rest for 3 months + 1 cannula / alternate days until completing 6 months (except for menstruation days) . |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Woman between the ages of 30 and 65 (both included).
- Able to read and understand the Patient Information Sheet and informed consent
- Accept participation in the study and sign the Informed Consent.
- Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
- Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
Key exclusion criteria (12 listed)
- Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
- Other cytological results other than those provided for in the inclusion criteria.
- Baseline LSIL biopsies with CIN-3.
- Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)
- Other symptomatic vulvovaginal infections.
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 |
|---|---|---|
| PAPILOCAREPapilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa. Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera. | Device | PAPILOCARE |
| LACTIC ACID GELThe lactic acid gel consists of a carrier gel with the absence of the active ingredients of Papilocare®. | Device | LACTIC ACID GEL |
Primary outcome
cervical mucosal repair
Time frame: 6 months
Percentage of patients with cervical lesions negativization confirmed be cytology and accordance colposcopy , at 6 months will be used to evaluate the main variables, degree of cervical mucosal repair in HPV-positive women with ASC-US or LSIL.
6 secondary outcomes
Reepithelialization degree of the cervical mucosa
Time frame: at 3 months
Percentage of patients with Viral clearance
Time frame: 3 and 6 months.
Vaginal health status measured by vaginal health index (VHI)
Time frame: 3 and 6 months.
Stress perceived by patients measured by PSS-14 (Perceived Stress Scale 14 items)
Time frame: 3 and 6 months.
Safety and tolerability of Papilocare® gel: Record of the incidence, nature and severity of adverse events
Time frame: 6 months
Satisfaction degree with Papilocare gel use: Likert type scale
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 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The PI from the participant site 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 will finish and the data will be analyzed, the PI will receive 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.
Alfonso Quesada López-Fe, Doctor principal investigator
H Nuestra Señora de la Candelaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAPILOCARE and LACTIC ACID GEL in people with HPV Infection and Lesion Cervix, run by Procare Health Iberia S.L. at 1 site 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 7 inclusion and 12 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
cervical mucosal repair (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 18 Dec 2025.