Topical sinecatechins ointment in treatment of primary superficial Basal Cell Carcinoma: a double blind, randomized, placebo-controlled trial.

Phase 2

Completed

Conditions: skincancer
Superficial basal cell carcinoma
10040900

Registration Number: NL-OMON40522

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

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

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 (see protocol picture 1)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is histological clearance of the target tumour<br /><br>(efficacy). This will be analysed by comparing the proportion of patients with<br /><br>complete histological clearance in the treatment group to placebo group<br /><br>assessed by two independent blinded dermato-pathologists.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Compliance, number of local skin reactions, adverse events and serious adverse<br /><br>events and histological effects of treatment with sinecatechins 10% ointment<br /><br>versus placebo.</p><br>