Can a gel heal HPV-Related cervical damage? new study says maybe
NCT ID NCT04210336
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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200 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Jan 2023
- Lead sponsor
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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
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30 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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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.
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- Could a Light-Activated cream replace surgery for cervical precancer?
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- Enzyme-HPV link in cervical disease explored
- Anesthesia choice may change surgical outcomes in cervical treatment