Clinical trial • Phase IV • Gastroenterology
Camellia sinensis (green tea) leaf extract for Anal high-grade squamous intraepithelial lesion (anal HSIL)
Phase IV trial of Camellia sinensis (green tea) leaf extract for Anal high-grade squamous intraepithelial lesion (anal HSIL).
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Anal high-grade squamous intraepithelial lesion (anal HSIL)
- Trial Stage
- Phase IV
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 12-12-2024
- First CTIS Authorization Date
- 24-03-2025
Trial design
Randomised, ablative treatment alone (topical ablative trichloroacetic acid) compared with topical sinecatechins 10% ointment used as adjuvant therapy to ablative treatment.-controlled Phase IV trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Ablative treatment alone (topical ablative trichloroacetic acid) compared with topical Sinecatechins 10% ointment used as adjuvant therapy to ablative treatment.
- Target Sample Size
- 150
- Trial Duration For Participant
- 336
Eligibility
Recruits 150 No vulnerable populations selected. Participants must be adults ≥ 18 years. Informed consent: "Voluntary signature of the informed consent." Subject information and consent forms provided (Spanish versions present). No assent procedure for minors (minors excluded)..
- Vulnerable Population
- No vulnerable populations selected. Participants must be adults ≥ 18 years. Informed consent: "Voluntary signature of the informed consent." Subject information and consent forms provided (Spanish versions present). No assent procedure for minors (minors excluded).
Inclusion criteria
- {"criterion_text":"- Adults ≥ 18 years of age."}
- {"criterion_text":"- HIV-1 infected individuals"}
- {"criterion_text":"- Individuals with biopsy-proven anal HSIL within 6 months prior to the study."}
- {"criterion_text":"- Voluntary signature of the informed consent."}
- {"criterion_text":"- Be able to understand and comply with protocol requirements, instructions, and restrictions."}
- {"criterion_text":"- Be likely to complete the study as planned."}
Exclusion criteria
- {"criterion_text":"- Any disease or condition of the patient that, in the opinion of the investigator, is not suitable for participation in the study."}
- {"criterion_text":"- Individuals who have received prior anal HSIL treatment in the last 3 months."}
- {"criterion_text":"- Individuals with two or more recurrences of anal HSIL in the last 2 years."}
- {"criterion_text":"- Individuals unable to understand the study protocol or any other condition that in the opinion of the investigator may compromise compliance with the protocol."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cumulative proportion of patients free of HSIL at 48 weeks post-treatment (with an allowed deviation of 8 weeks).","definition_or_measurement_approach":"Proportion of patients free of HSIL at 48 weeks post-treatment, defined as a complete or partial response (regression from HSIL to normal or LSIL, respectively) and free of recurrence."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 36
- Consent Approach
- Voluntary signature of the informed consent by participants (adults ≥ 18). Subject information and informed consent forms available in Spanish (documents titled L1_SIS and ICF_ESP and Spanish versions). No assent for minors as they are excluded.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 150
Spain
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 21-08-2025
- Processing Time Days
- 175
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Infectious diseases
- Principal Investigator Name
- Joaquín Burgos
- Principal Investigator Email
- joaquin.burgos@vallhebron.cat
- Contact Person Name
- Joaquín Burgos
- Contact Person Email
- joaquin.burgos@vallhebron.cat
Sponsor
Primary sponsor
- Full Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"","full_name":"Fundació La Marató TV3","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- SINECATECHINS
- Active Substance
- Camellia sinensis (green tea) leaf extract
- Modality
- Other
- Routes Of Administration
- Cutaneous use
- Route
- Cutaneous use
- Authorisation Status
- prodAuthStatus=2 (no marketing authorisation number provided)
- Maximum Dose
- maxDailyDoseAmount: 0.75 mg; maxTotalDoseAmount: 163 mg
- Combination Treatment
- Yes
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