NCT06098456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

October 19, 2023

Last Update Submit

July 12, 2024

Conditions

Papilloma-induced Cervical Lesions

Keywords

EGCGHPVFolic acidHyaluronic acidVitamin B12LSIL

Outcome Measures

Primary Outcomes (1)

  • Positivity to HPV infection

    The outcome consists of the number of negative DNA-test obtained in patients previously positive.

    3 and 6 months

Secondary Outcomes (2)

  • Occurrence of lesions

    3 and 6 months

  • Lesions-related symptmos

    3 and 6 months

Study Arms (2)

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.

Drug: EGCG, FA, HA, B12

Control

NO INTERVENTION

The patients in this group follow the routine clinical practice, namely the clinical monitoring.

Interventions

EGCG, FA, HA, B12DRUG

Epigallocatechin gallate 200mg, Hyaluronic acid 50mg, Vitamin B12 1mg, Folic acid 400mcg

Also known as: Pervistop
Treatment

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positivity to HPV-DNA test
  • PAP-test reporting LSIL or ASCUS

You may not qualify if:

  • HPV-related pathologies or complicances apart from LSIL or ASCUS
  • Diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

Location

MeSH Terms

Interventions

epigallocatechin gallateVitamin B 12

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 24, 2023

Study Start

November 1, 2023

Primary Completion

May 15, 2024

Study Completion

June 28, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

IT(1)