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Study on the Effectiveness of Green Tea Extract and Trichloroacetic Acid for Treating Anal High-Grade Squamous Intraepithelial Lesions in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms your voluntary participation and understanding of the study's requirements.

    You must be at least 18 years old, have a confirmed diagnosis of anal high-grade squamous intraepithelial lesions (HSIL) within the last six months, and be able to follow the study's instructions.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history and a physical examination.

    The assessment ensures that you meet all the necessary criteria to participate in the study.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive a topical treatment with Sinecatechins 10% ointment. This is applied to the affected area on the skin.

    The ointment is used as an additional therapy alongside a procedure called ablative treatment, which aims to remove the lesions.

    The treatment will last for up to 48 weeks, with the goal of reducing or eliminating the lesions.

  4. Step 4

    Regular follow-up visits

    You will have regular follow-up visits with the study team to monitor your progress. These visits are important to assess the effectiveness of the treatment and to check for any side effects.

    During these visits, you may undergo physical examinations and provide feedback on your experience with the treatment.

  5. Step 5

    Final assessment

    At the end of the 48-week treatment period, a final assessment will be conducted to evaluate the outcome of the treatment.

    The main objective is to determine if the lesions have been reduced or eliminated and to ensure there is no recurrence.

Who can join the trial?

6 criteria

  • Adults who are 18 years of age or older.
  • Individuals who are infected with HIV-1.
  • Individuals who have been diagnosed with anal high-grade squamous intraepithelial lesions (HSIL) through a biopsy within the last 6 months.
  • Individuals who have voluntarily signed the informed consent form, which means they agree to participate in the study after being informed about it.
  • Individuals who are able to understand and follow the study's requirements, instructions, and restrictions.
  • Individuals who are likely to complete the study as planned.

Who cannot join the trial?

5 criteria

  • Patients who are not free of **high-grade squamous intraepithelial lesions (HSIL)** after 48 weeks of treatment cannot participate. HSIL refers to abnormal cells found on the surface of the anal canal that could become cancerous if not treated.
  • Patients who do not respond to treatment with **Sinecatechins 10% ointment** as an additional therapy to ablative treatment are excluded. Sinecatechins is a topical ointment used to treat certain types of skin lesions.
  • Patients who experience a recurrence of HSIL after treatment are not eligible. Recurrence means the return of the lesions after they have been treated.
  • Both **male and female** patients can participate, but those who do not meet the gender criteria are excluded.
  • Patients who are part of a **vulnerable population** are not eligible. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of being harmed by the study.
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Investigated drugs

  • Sinecatechins

    is a topical ointment used in this clinical trial as an additional treatment to help manage anal high-grade squamous intraepithelial lesions (HSIL). It is applied directly to the affected area on the skin. The main goal of using Sinecatechins in this study is to see if it can help reduce or eliminate the lesions when used alongside another treatment. This ointment is derived from green tea leaves and is known for its ability to help the body fight off certain types of skin growths.

  • Trichloroacetic Acid

    is used in this trial as a topical ablative treatment. This means it is applied directly to the skin to remove or destroy the abnormal tissue. In this study, Trichloroacetic Acid is used to treat anal high-grade squamous intraepithelial lesions (HSIL) by breaking down the unwanted tissue, allowing for new, healthy tissue to grow in its place. The study is investigating how effective this treatment is on its own and when used together with Sinecatechins.

What is already known about the treatment

Sinecatechins – Sinecatechins is a topical ointment applied directly to the skin, specifically used in the treatment of anal high-grade squamous intraepithelial lesions (HSIL). It is currently being studied in clinical trials as an additional therapy to enhance the effects of trichloroacetic acid, a substance used to remove abnormal tissue. The main goal of using Sinecatechins is to help reduce or eliminate these lesions and prevent their recurrence. At the molecular level, Sinecatechins work by harnessing the antioxidant properties of green tea extracts, which help to inhibit the growth of abnormal cells. It is classified as a botanical drug, derived from natural plant sources, and is being explored for its potential benefits in treating specific skin conditions.

Investigated diseases

Anal high-grade squamous intraepithelial lesions (HSIL) – Anal high-grade squamous intraepithelial lesions are abnormal growths found in the anal canal. These lesions are considered precancerous, meaning they have the potential to develop into anal cancer if left untreated. HSIL is characterized by the presence of abnormal cells that appear different from normal cells under a microscope. The progression of HSIL can vary, with some lesions remaining stable or regressing, while others may progress to cancer. The condition is often associated with human papillomavirus (HPV) infection, which can cause changes in the cells of the anal lining. Monitoring and management are important to prevent progression to more severe conditions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519782-21-00Protocol codeSINECHSILEstimated enrolment150 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).