Basal Cell Carcinoma
Conditions
Interventions
Trade Name: Diclofenac (Voltaren)
Product Name: Diclofenac (Voltaren)
Product Code: 15307-86-5
Pharmaceutical Form: Gel
INN or Proposed INN: DICLOFENAC
CAS Number: 15307-86-5
Concentration unit: g gra
Sponsors
MUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Minimum age 18 years Primary basal cell carcinoma, histologically confirmed Nodular of micronodular histological subtype Comorbidities may not interfere with study treatment 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To asses macroscopic tumour changes, toleration of the therapy and patient satisfaction. ;Main Objective: To determine whether topical application of Calcitriol (Silkis) 3 µg/g, Diclofenac 10% or a combination of both can lead to a 40% histological reduction (?)/increase (?) of expression of the following antibodies: Ki67 (?), BCL2 (?), Caspase 3 (?) and Cox2 (?) (proliferation and apoptosis), LC3B (?) (autophagy), HIF1a (?) (hypoxia), ß-catenin (?), sFRP4 (?) and sFRP5 (?) (Wnt pathway activity). ;Primary end point(s): significant reduction or increase (=40%) in expression of the different antibodies tumor tissue of the biopsy and the therapeutic excission will be tested. The intensity of the staining will be taken into account. The following antibodies will be tested: • Ki67 • ?-catenin • BCL2 • Caspase 3 • Cox2 • LC3b • Hif1a • sFRP4 • sFRP5 | — |
Countries
Netherlands
Outcome results
None listed