Topical Itraconazole in the Treatment of Basal Cell Carcinoma

• Status: Completed
• Trial end date: 2019-01-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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