Enrolling by invitation

TrichlosilTopical Trichloroacetic Acid for HPV-Related Low-Grade Cervical Lesions

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What is being tested

85%TCA topical application

+ 3% acetic acid

Drug
Who is being recruted

Squamous Intraepithelial Lesions+10

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorDepartment of Medical Services Ministry of Public Health of Thailand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEfficacy of Topical 85%Trichloroacetic Acid in the Treatment of Low-grade Squamous Intraepithelial Lesion (LSIL) After Low-grade Abnormality of Screening Test: a Randomized Controlled Trial
NCT06525870
Principal SponsorDepartment of Medical Services Ministry of Public Health of Thailand
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Squamous Intraepithelial LesionsUrogenital DiseasesGenital DiseasesUterine Cervical DiseasesUterine Cervical DysplasiaFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleNeoplasmsPrecancerous ConditionsPathological Conditions, Signs and SymptomsUterine DiseasesFemale Urogenital DiseasesMorphological and Microscopic Findings

Criteria

2 inclusion criteria required to participate
Women, 18-65 years of age, colposcopic biopsy confirmed CIN1 or HPV (LSIL) preceded by low-grade cervical screening test, i.e. ASCUS HPV positive, LSIL, HPV 16/18 positive, persistent high-risk HPV infection.

Willing to participate in this trial

3 exclusion criteria prevent from participating
Women diagnosed with previous or concurrent invasive carcinoma of the cervix

Women with history of pelvic radiotherapy

Pregnant women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive 85%TCA topical application at cervical lesion and transformation zone. Application of TCA will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators.

Group II

Placebo
Participants will receive 3% acetic acid topical application at cervical lesion and transformation zone. Application of 3% acetic acid will be guided by colposcopy using a small cotton-tipped applicators and wooden end of the applicators.

Study 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

Suspended

Rajavithi Hospital

Thailand, ThailandOpen Rajavithi Hospital in Google Maps
Enrolling by invitationOne Study Center