Topical Vitamin D3, Diclofenac or a combination of both to treat Basal Cell Carcinoma

Phase 3

Completed

Conditions: basal cell carcinoma
non-melanoma skin cancer
10040900

Registration Number: NL-OMON36360

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 128

Inclusion Criteria

Minimum age 18 years
Primary basal cell carcinoma > 4 mm, histologically confirmed
(Micro) nodular or superficial histological subtype
Comorbidities may not interfere with study treatment
Capable to understand instructions

Exclusion Criteria

Age under 18 years
Tumors located at the H-zone of the face
Deficient histological conformation
Proven or suspected malignancy of other organs
Not capable of comprehending instructions
Incompetent
Use of oral NSAIDs during the trial period or within 30 days before starting therapy
Use of oral vitamin D (containing) supplements during the trial period or within 30 days before starting therapy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A significant reduction or increase (=40%) in expression of the different<br /><br>antibodies tumor tissue of the biopsy and the therapeutic excission will be<br /><br>tested. The intensity of the staining will be taken into account.<br /><br>The following antibodies will be tested:<br /><br><br /><br><br /><br>• Ki67<br /><br>• *-catenin<br /><br>• BCL2<br /><br>• Caspase 3<br /><br>• Cox2<br /><br>• LC3b<br /><br>• Hif1a<br /><br>• sFRP4<br /><br>• sFRP5</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Macroscopic tumour changes<br /><br>* Toleration of therapy<br /><br>* Patient satisfaction<br /><br><br /><br>Both tolerance and satisfaction will be asses by diaries and questionnaires. </p><br>