Overview
Sponsor-declared trial summary
Anal high-grade squamous intraepithelial lesions (HSIL).
To describe the proportion of patients free of HSIL at 48 weeks of treatment, defined as a complete or partial response (regression from HSIL to normal or LSIL, respectively) and free of recurrence, with topical Sinecatechins 10% ointment used as adjuvant therapy to ablative treatment, compared with ablative treatment …
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 18 Sep 2025 → ongoing
- Decision date (initial)
- 2025-03-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fundació La Marató TV3
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To describe the proportion of patients free of HSIL at 48 weeks of treatment, defined as a complete or partial response (regression from HSIL to normal or LSIL, respectively) and free of recurrence, with topical Sinecatechins 10% ointment used as adjuvant therapy to ablative treatment, compared with ablative treatment alone.
Conditions and MedDRA coding
Anal high-grade squamous intraepithelial lesions (HSIL).
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Adults ≥ 18 years of age.
- HIV-1 infected individuals
- Individuals with biopsy-proven anal HSIL within 6 months prior to the study.
- Voluntary signature of the informed consent.
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Be likely to complete the study as planned.
Exclusion criteria 4
- Any disease or condition of the patient that, in the opinion of the investigator, is not suitable for participation in the study.
- Individuals who have received prior anal HSIL treatment in the last 3 months.
- Individuals with two or more recurrences of anal HSIL in the last 2 years.
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- Cumulative proportion of patients free of HSIL at 48 weeks post-treatment (with an allowed deviation of 8 weeks).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Camellia Sinensis (Green Tea) Leaf Extract
SCP21419871 · ATC
- Active substance
- Camellia Sinensis (Green Tea) Leaf Extract
- Substance synonyms
- GREEN TEA, GREEN TEA EXTRACT
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0.75 mg milligram(s)
- Max total dose
- 163 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- D06BB12 — SINECATECHINS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Dr. Joaquin Burgos
Public contact point
- Organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Contact name
- Dr. Joaquin Burgos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-09-18 | 2025-10-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT EU-CT2024-519782-21-00 | 1 |
| Protocol (for publication) | D1_Protocol_SM1_EU-CT_2024-519782-21-00_cc | 2 |
| Protocol (for publication) | D1_Protocol_SM1_EU-CT_2024-519782-21-00_clean | 2 |
| Protocol (for publication) | D4_Cuestionario de Adherencia | 1 |
| Protocol (for publication) | D4_Cuestionario de Calidad de vida | 1 |
| Protocol (for publication) | D4_Cuestionario de Satisfaccion | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_HIP_SINECHSIL_V1_27FEB2025_cc | 1 |
| Subject information and informed consent form (for publication) | L1_HIP_SINECHSIL_V1_27FEB2025_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_17FEB2025_clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ESP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ESP_17FEB2025_cc | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Spanish_EU-CT_2024-519782-21-00_clean | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Spanish_EU-CT_2024-519782-21-00_SM1_cc | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Veregen | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2024-519782-21-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Spanish_SM1_EU-CT_2024-519782-21-00_cc | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Spanish_SM1_EU-CT_2024-519782-21-00_clean | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-12 | Spain | Acceptable 2025-02-25
|
2025-03-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-07 | Spain | Acceptable 2025-08-19
|
2025-08-21 |