Basal cell carcinoma MedDRA version: 14.1 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10004148 Term: Basal cell carcinoma excision System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Sporanox Kapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ITRACONAZOLE
CAS Number: 84625-61-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Med Uni Graz, Univ. Klinik Dermatologie,Abteilung für Allgemeine Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Legally competent male and female individuals over 18 years of age • Patients with histopathologically confirmed BCC with a clinical size of at least 5x5 mm after biopsy, equalling a minimum size of 8x8 mm prior to biopsy • Microscopically confirmed onychomycosis • Informed consent to the study • Patients who already take Itraconazole treating their onychomycosis are applicable for the study if their BCC was biopsied prior to the start of Itraconazole therapy 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Individuals with nevoid basal cell carcinoma syndrome • Prior local therapies of the BCC • Excision planned in less than 8 or more than 14 weeks from start of Itraconazole therapy for verum group • Treatment with Itraconazole or other systemic antifungal drugs within the last 2 years • Contraindications against treatment with Itraconazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Quantitative PCR will be performed to evaluate if Itraconazole leads to a significant inhibition of the Hedgehog pathway demonstrated by a significant reduction in the mRNA expression levels of GLI1, PTCH1, SMO and BCL2 in basal cell carcinomas. In addition, immunohistochemistry will be performed to analyze the changes on protein expression of GLI1, PTCH1 and SMO caused by Itrazonazole treatment.;Secondary Objective: A clinical evaluable anti-tumor effect of Itraconazole will be determined as impact on BCC tumor size by imaging and clinical assessment of all lesions at study entry and prior to excision. In order to elucidate the anti tumor effect of Itraconazole on cell level, we will determine the histopathological necrosis score on haematoxylin and eosin stained sections of all biopsies and excised basal cell carcinomas. The induction of apoptosis will be quantified immunohistochemically by staining for cleaved caspase 3.;Primary end point(s): Inhibition of the Hedgehog pathway, represented through the reduction of the GLI1 expression;Timepoint(s) of evaluation of this end point: after collection of all samples | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A clinical evaluable anti-tumor effect of Itraconazole will be determined as impact on BCC tumor size by imaging and clinical assessment of all lesions at study entry and prior to excision. In order to elucidate the anti tumor effect of Itraconazole on cell level, we will determine the histopathological necrosis score on haematoxylin and eosinstained sections of all biopsies and excised basal cell carcinomas. The induction of apoptosis will be quantified immunohistochemically by staining for cleaved caspase 3.;Timepoint(s) of evaluation of this end point: after collection of all samples | — |
Countries
Austria
Contacts
Public ContactInformation Klinische Studien
Med Uni Graz, Abteilung für Allgemeine Dermatologie
Outcome results
None listed