NCT06188104

Efficacy of Topical 95% TCA in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test

Efficacy of Topical 95% Trichloroaceteic Acid in the Treatment of CIN 1 or Less After Low-grade Abnormality of Screening Test: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test

Detailed description

The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination. Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group. We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment) In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group \* During colposcopic examination, we also repeat cytologic examination and HPV testing as well \*\* Pregnancy test is done before applying 95%Trichloroacetic acid and at the time of follow-up. If positive at any point of time, participants are excluded from the study

Conditions

• CIN1
• Trichloroacetic Acid

Interventions

Type	Name	Description
DRUG	Trichloroacetic acid	Applying Trichloroacetic acid 95 % topical solution plus acetic acid at the transformation zone or lesion (if have) of the cervix during colposcopic examination (95% topical trichloroacetic acid is used just before finishing examination, while acetic acid is used normally when perform colposcopy)

Timeline

• Start date: 2023-11-30
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Thailand