Topical green tea ointment in treatment of superficial skin cancer.

Phase 1

• Conditions: Primary histological proven superficial basal cell carcinoma = 4mm < 20mm outside the H-zone of the face or scalp; MedDRA version: 17.0Level: LLTClassification code 10042503Term: Superficial basal cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005439-26-NL
• Lead Sponsor: Maastricht University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-13
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

- Adults aged 18 years or older
- Primary histological proven superficial basal cell carcinoma = 4mm and = 20mm
- Comorbidities may not interfere with study treatment (evaluated by investigator)
- Capable to understand instructions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

- Recurrent sBCC (previous treatment)
- Breast-feeding or pregnant women
- Serious comorbidities
- Use of immunosuppressive medication during the trial period or within 30 days before enrolment
- Patients with genetic skin cancer disorders
- Tumour located in the H zone (high-risk area of face) or scalp

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether topical sinecatechins 10% (Veregen®) ointment application can lead to a histological clearance (efficacy) of a superficial basal cell carcinoma. <br><br>;Secondary Objective: To assess clinical clearance, compliance and adverse reactions (safety). To assess other histological effects with additional immunohistochemic stains; Bcl-2 (anti-apoptosis), Ki67 (proliferation).;Primary end point(s): The main study parameter is histological clearance of the target tumour (efficacy). This will be analysed by comparing the proportion of patients with complete histological clearance in the treatment group to placebo group assessed by two independent blinded dermato-pathologists. ;Timepoint(s) of evaluation of this end point: At the end of the trial after surgical excision.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Compliance, number of local skin reactions, adverse events and serious adverse events and histological effects (immunohistochemical stains Ki67 and Bcl-2) of treatment with sinecatechins 10% ointment versus placebo.;Timepoint(s) of evaluation of this end point: Complicance at 6 weeks in patient diary and weight tubes.<br>Lokal skin reactions in subjective patient diary and objective at control visit after 3, 6 and 8 weeks.<br>Histological effects after surgical excision in week 8.