Topical Itraconazole in the Treatment of Basal Cell Carcinoma

Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although
rarely metastatic, it can be locally destructive causing disfigurement and pain. Current
therapies include surgical removal, local destruction, radiotherapy and others.

Advances in understanding the molecular basis behind BCCs indicate that mutations in the
hedgehog signaling pathway can lead to the development of many sporadically occurring basal
cell carcinomas (BCCs). An oral drug that targets the hedgehog signaling pathway has been
shown to be effective in treating patients with metastatic and inoperable BCCs. There is
evidence that itraconazole, a commonly prescribed antifungal medication may also affect this
pathway. It is not known whether itraconazole ointment applied topically can affect the
growth of BCCs.

Inclusion Criteria:

- Participants must be over the age of 18 years

- Male

- Women who do not have child-bearing potential (history of hysterectomy,
post-menopausal)

- Have a biopsy confirmed BCC that measures at least 6mm in size at the time of the
initial evaluation (visit #1);

- Participant must be willing and comply with the requirements of the protocol;

- Participant must have the ability to understand and communicate with the investigator;

- Participant must provide informed consent.

Exclusion Criteria:

- Subject with significant congestive heart failure (CHF) or history of CHF, chronic
renal failure, hepatic failure, neuropathy

- Subject with current skin diseases that the investigator feels is not safe for study
participation including but not limited to severe atopic dermatitis, cutaneous T-cell
lymphoma, erythroderma;

- Subjects on systemic medications known to affect the Hedgehog pathway (see Appendix I)

- Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine,
dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin,
simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and
methylergometrine (methylergonovine), cisapride, pimozide, methadone,
levacetylmethadol (levomethadyl), quinidine

- Subjects with history of hypersensitivity to azoles

- Subjects with Gorlin syndrome

- Subjects on chronic immunosuppression, or who have a history of compromised immune
function (e.g. history of or current malignancy other than BCC/squamous cell skin
cancers)

- Subjects who do not speak English or have difficulty hearing or are otherwise impaired
for providing informed consent and communicating with the investigator;

- Subjects with a history of keloids or excessive scarring;

- Subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum

- Women of child-bearing age/potential and/or able to conceive