Topical Itraconazole in the Treatment of Basal Cell Carcinoma

Johns Hopkins University

Status and phase: Completed; Early Phase 1

Conditions: Basal Cell Carcinoma

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02120677

NA_00077461

Details and patient eligibility

About

This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Itraconazole ointment

Experimental group

Description:

Patients with histologically proven BCC will be eligible for study enrollment. 50% itraconazole compounded in petrolatum jelly will be applied under occlusion for up to 3 to 7 days.

Treatment:

Drug: Itraconazole