TrichlosilTopical Trichloroacetic Acid for HPV-Related Low-Grade Cervical Lesions
85%TCA topical application
+ 3% acetic acid
Squamous Intraepithelial Lesions+10
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: August 1, 2024
Actual date on which the first participant was enrolled.This clinical trial is exploring the effectiveness of using a topical solution called 85% Trichloroacetic Acid (TCA) for women aged 18 to 65 who have been diagnosed with low-grade squamous intraepithelial lesions (LSIL) caused by human papillomavirus (HPV). The study is focused on women who have been referred to a colposcopy clinic due to abnormalities found in cervical screening tests, such as ASC-US, LSIL, or persistent high-risk HPV infections. The aim is to see if applying TCA can clear the HPV infection and lead to complete remission of these cervical lesions, potentially offering a new treatment option to improve patient outcomes. Participants in the study are randomly divided into two groups. One group receives the TCA treatment applied directly to the affected cervical areas using a cotton-tipped applicator, while the other group receives a placebo treatment using 3% acetic acid applied in the same way. After the treatment, participants are monitored for any discomfort and advised on post-treatment care. They are followed up after two weeks and again after three months to check for healing and any changes in their condition. The main goal is to see if there is complete remission of the lesions and whether there is clearance of the specific HPV type involved. The study will measure these outcomes through examinations and tests, aiming to provide evidence on the efficacy of TCA in treating LSIL.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.44 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location