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Can a gel heal HPV-Related cervical damage? new study says maybe

NCT ID NCT04210336

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a gel called Papilocare can help repair cervical lesions caused by HPV. About 200 women aged 30 to 65 with mild cervical changes used either Papilocare or a lactic acid gel for 6 months. The goal was to see if the gel could clear the lesions and the virus, but ongoing monitoring is needed since HPV can come back.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Aug 2018

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Woman between the ages of 30 and 65 (both included). 2. Able to read and understand the Patient Information Sheet and informed consent 3. Accept participation in the study and sign the Informed Consent. 4. 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. 5. 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). 6. Women vaccinated and not vaccinated against HPV. 7. 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. Exclusion Criteria: 1. Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants. 2. Other cytological results other than those provided for in the inclusion criteria. 3. Baseline LSIL biopsies with CIN-3. 4. Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit) 5. Other symptomatic vulvovaginal infections. 6. Surgical cervical excision in the last year or total hysterectomy. 7. Previous history of gynecological cancer. 8. Participation in any other clinical trial at present or in the 4 weeks prior to inclusion of the study. 9. Any planned surgery that precludes correct compliance with the guideline. 10. Use of vaginal contraceptives or other vaginal hormonal treatments. 11. Contraindications to the use of Papilocare® gel or known allergies to any of its components. 12. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspected pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Universitario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, Tenerife, 38010, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.