Clinical Research Directory

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

Sponsor: Department of Medical Services Ministry of Public Health of Thailand

Summary

To determine the efficacy and HPV clearance of an application of 85% TCA compared to placebo in the treatment of LSIL. This is a randomized, single-blind, placebo-controlled study in 44 women aged 18-65 years with histologic-proved HPV/CIN1. The study will test whether 85% TCA application will be effective treatment in LSIL. The clinical study hypothesis is that TCA application at cervical lesion and transformation zone will achieve histologic complete remission of LSIL in significantly more patients than placebo therapy. Patients will be randomized to placebo (3% acetic acid) or 85%TCA topical application at cervical lesion and transformation zone. After 3 months, cytology, colposcopy, histology, and HPV testing will be performed. The primary endpoint is treatment efficacy defined as complete histologic remission at 3 months after treatment. The secondary endpoint is HPV clearance 3 months after treatment. The protocol for the project is approved by an Institutional Review Board (IRB). Project is totally supported by a grant from Rajavithi Hospital. There is no external funding.

Official title: Efficacy 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

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