This clinical trial is focused on studying a condition known as anal high-grade squamous intraepithelial lesions (HSIL). This condition involves abnormal cell growth in the anal area, which can potentially lead to cancer if not treated. The study is testing a treatment that combines two approaches: a topical ointment called Sinecatechins, which is derived from green tea extract, and a procedure using a chemical called trichloroacetic acid to remove abnormal tissue.
The purpose of the study is to see how effective the combination of these treatments is in helping patients become free of HSIL after 48 weeks. Participants will be randomly assigned to receive either the combination of Sinecatechins and the chemical procedure or the chemical procedure alone. The study will monitor the participants over a period of time to see if the lesions improve or disappear and if they stay away.
Participants in the study will apply the Sinecatechins ointment to the affected area as directed, in addition to undergoing the chemical procedure. The study aims to determine if adding the ointment helps more patients achieve a complete or partial response, meaning the lesions either return to normal or become less severe. The trial will last for about 48 weeks, with some flexibility in timing, to assess the long-term effectiveness of the treatment.
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