Efficacy of Topical Sinecatechins as Adjuvant to Trichloroacetic Acid in Treating Anal High-Grade Squamous Intraepithelial Lesions

The primary objective of this randomized controlled study is to evaluate the **efficacy** of topical Sinecatechins 10% ointment as an adjuvant therapy to topical ablative trichloroacetic acid in the treatment of **anal high-grade squamous intraepithelial lesions (HSIL)**. The study aims to determine the proportion of patients who are free of HSIL at 48 weeks of treatment. This is defined as achieving a complete or partial response, which involves regression from HSIL to normal or low-grade squamous intraepithelial lesions (LSIL), and being free of recurrence. The clinical relevance of this objective lies in potentially improving treatment outcomes for patients with HSIL by reducing lesion recurrence and promoting lesion regression when using Sinecatechins in conjunction with ablative treatment.

The clinical trial involves a study population comprising **adults aged 18 years and older**, including both male and female participants. The trial specifically targets individuals who are **HIV-1 infected** and have biopsy-proven **anal high-grade squamous intraepithelial lesions (HSIL)** within six months prior to the study. Participants are required to voluntarily sign informed consent and demonstrate the ability to understand and comply with protocol requirements. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed as a **randomized controlled study** to evaluate the efficacy of topical Sinecatechins as an adjuvant therapy to topical ablative trichloroacetic acid in the treatment of **anal high-grade squamous intraepithelial lesions (HSIL)**. The trial aims to determine the proportion of patients free of HSIL at 48 weeks of treatment, with a focus on achieving a complete or partial response and preventing recurrence. The study will involve adult participants aged 18 years and older, including those infected with HIV-1, who have biopsy-proven anal HSIL within six months prior to the study. Participants must voluntarily sign informed consent and demonstrate the ability to comply with protocol requirements.

The trial will be conducted over an estimated duration from March 2025 to February 2028. Participants will be involved for a maximum treatment period of three months, with the primary endpoint being the cumulative proportion of patients free of HSIL at 48 weeks post-treatment, allowing for an 8-week deviation. The study will include several key visits: an initial **screening visit** to confirm eligibility, followed by regular follow-up visits to monitor treatment progress and assess outcomes. The **end-of-study visit** will evaluate the final treatment response and any recurrence of HSIL.

Participants may be subject to early termination from the study if they fail to adhere to the protocol, experience adverse effects that necessitate discontinuation, or withdraw consent. The trial is not classified as a low-intervention study and is categorized as a Phase IV trial, indicating its focus on post-marketing surveillance and long-term efficacy assessment. The investigational product, Sinecatechins, will be administered cutaneously, with a maximum daily dose of 0.75 mg and a total dose not exceeding 163 mg over the treatment period. The study's rigorous design and comprehensive follow-up aim to provide valuable insights into the therapeutic potential of Sinecatechins in managing anal HSIL.

The clinical trial involves the use of **Sinecatechins**, a topical formulation containing **camellia sinensis (green tea) leaf extract** as the active substance. This experimental medication is administered in the form of an ointment, specifically designed for **cutaneous use**. The concentration of the active ingredient in the ointment is 10%. The maximum daily dose is 0.75 mg, with a total maximum dose of 163 mg over the treatment period. The treatment is applied topically, and the maximum treatment period is three months. The ointment is not a pediatric formulation and is classified under the ATC code D06BB12, indicating its use in dermatological applications.

In this study, **Sinecatechins** is used as an adjuvant therapy in conjunction with standard-of-care treatment, which involves the use of topical ablative trichloroacetic acid. The primary objective is to evaluate the efficacy of **Sinecatechins** in achieving a complete or partial response in patients with anal high-grade squamous intraepithelial lesions (HSIL) when used alongside the ablative treatment. The study aims to determine the proportion of patients who are free of HSIL at 48 weeks, defined as a regression from HSIL to normal or low-grade squamous intraepithelial lesions (LSIL), and free of recurrence.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment regimen. The trial does not involve the use of a placebo or other comparator treatments, as the focus is on the combination of **Sinecatechins** with the existing standard-of-care therapy. The study is designed to provide insights into the potential benefits of integrating **Sinecatechins** into the treatment protocol for patients with anal HSIL.

The efficacy of the clinical trial will be assessed by evaluating the **cumulative proportion of patients free of High-Grade Squamous Intraepithelial Lesion (HSIL)** at 48 weeks post-treatment, with an allowed deviation of 8 weeks. This primary endpoint will determine the effectiveness of topical Sinecatechins 10% ointment used as adjuvant therapy to ablative treatment, compared with ablative treatment alone. The main objective is to describe the proportion of patients achieving a complete or partial response, defined as regression from HSIL to normal or Low-Grade Squamous Intraepithelial Lesion (LSIL), and remaining free of recurrence.