Papilloma-induced Cervical LesionsPhase 2EGCGHPVNCT06098456
Epigallocatechin Gallate and Other Antural Compounds in HPV Infections
A Phase 2 study testing EGCG, FA, HA, B12 in people with Papilloma-induced Cervical Lesions, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.
Trial summary
The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS. Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route. After three months of treatment PAP-test and HPV-DNA test will be repeated. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Papilloma-induced Cervical Lesions
- What is being tested?
- EGCG, FA, HA, B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 28 Jun 2024
- Phase
- Phase 2
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Positivity to HPV-DNA test
- PAP-test reporting LSIL or ASCUS
Who cannot join
- HPV-related pathologies or complicances apart from LSIL or ASCUS
- Diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.
Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.
After three months of treatment PAP-test and HPV-DNA test will be repeated.
- Conditions
- Papilloma-induced Cervical Lesions
- Being tested
- EGCG, FA, HA, B12
- Keywords
- EGCG, HPV, Folic acid, Hyaluronic acid, Vitamin B12, LSIL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCG, FA, HA, B12Drug
Also called Pervistop
Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day. Receives: Drug: EGCG, FA, HA, B12 |
| Control | No intervention | The patients in this group follow the routine clinical practice, namely the clinical monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity to HPV infection
The outcome consists of the number of negative DNA-test obtained in patients previously positive.
Measured: 3 and 6 months
Secondary outcomes (2)
Occurrence of lesions
The outcome consists of the number of negative PAP-tests obtained in patients previously positive.
Measured: 3 and 6 months
Lesions-related symptmos
The ouctome includes the occurrence of bleeding, flogosis, or sexual pain.
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 Oct 2023
- Study start1 Nov 2023
- Primary completion15 May 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilloma-induced Cervical LesionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Ricerca Clinica Salentino
- Sponsor type
- Research network
- Responsible party
- Principal investigator, ANDREA TINELLI, Centro di Ricerca Clinica Salentino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098456
- Sponsor's protocol ID
- HPV-EGCG
- Acronym
- EGCGHPV
- Status last verified
- Jul 2024
- First submitted
- 19 Oct 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
- ClinicalTrials.gov ID
- NCT06098456
- Acronym / sponsor ID
- EGCGHPV / HPV-EGCG
- Conditions
- Papilloma-induced Cervical Lesions
- Keywords
- EGCG, HPV, Folic acid, Hyaluronic acid, Vitamin B12, LSIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Centro di Ricerca Clinica SalentinoResearch network
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 24 Oct 2023 (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.
The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.
Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.
After three months of treatment PAP-test and HPV-DNA test will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: EGCG, FA, HA, B12The patients in this group undergo treatment with Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg and Folic acid 400mcg by oral route once per day. |
| Control | No intervention | –The patients in this group follow the routine clinical practice, namely the clinical monitoring. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Positivity to HPV-DNA test
- PAP-test reporting LSIL or ASCUS
Key exclusion criteria (2 listed)
- HPV-related pathologies or complicances apart from LSIL or ASCUS
- Diagnosis of cancer
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 |
|---|---|---|
| EGCG, FA, HA, B12Also: PervistopEpigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg | Drug | Treatment |
Primary outcome
Positivity to HPV infection
Time frame: 3 and 6 months
The outcome consists of the number of negative DNA-test obtained in patients previously positive.
2 secondary outcomes
Occurrence of lesions
Time frame: 3 and 6 months
Lesions-related symptmos
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 15 Jul 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGCG, FA, HA, B12 in people with Papilloma-induced Cervical Lesions, run by Centro di Ricerca Clinica Salentino at 1 site in Italy.
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 2 inclusion and 2 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 15 Jul 2024. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Positivity to HPV infection (time frame: 3 and 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 15 Jul 2024.