Efficacy of Topical 85% TCA in the Treatment of LSIL After Low-grade Abnormality of Screening Test: a Randomized Controlled Trial

Launched by DEPARTMENT OF MEDICAL SERVICES MINISTRY OF PUBLIC HEALTH OF THAILAND · Jul 24, 2024

Keywords

ClinConnect Summary

This trial in Thailand is testing whether applying 85% trichloroacetic acid (TCA) to a cervical lesion helps restore normal tissue better than a harmless comparison treatment (3% acetic acid) in women with low-grade cervical changes (CIN1/LSIL). It is a randomized, single-blind study enrolling about 44 women aged 18–65, conducted at Rajavithi Hospital in Bangkok. The main goal is to see if 3 months after treatment there is complete histologic remission, meaning biopsy results show normal cervical tissue. A secondary goal is to see whether the HPV infection present at the start becomes undetectable (HPV clearance). The study is IRB-approved and funded by the hospital.

Participants will be randomly assigned to Group 1 (85% TCA) or Group 2 (3% acetic acid). The medicine is applied to the cervix under colposcopy, guided to cover the lesion and surrounding transformation zone. Because the appearance of tissue whitening can reveal the treatment, patients won’t be blinded to their group, but they won’t know which treatment they received. After treatment, follow-up visits occur at 2 weeks and then at 3 months, including cytology (Pap-like test), an HPV test, and a colposcopy with biopsies to assess remission and HPV status. Key eligibility includes women 18–65 with CIN1/LSIL or HPV-positive low-grade changes; exclusions include pregnancy, prior pelvic radiotherapy, or invasive cervical cancer. The trial uses an intention-to-treat analysis and aims to provide information on the potential benefit and safety of 85% TCA for LSIL.

Gender

FEMALE

Eligibility criteria

• • Inclusion criteria
• • 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
• • Exclusion criteria
• • Women diagnosed with previous or concurrent invasive carcinoma of the cervix
• • Women with history of pelvic radiotherapy
• • Pregnant women