Topical Itraconazole in the Treatment of Basal Cell Carcinoma

Completed · Early Phase 1

Conditions studied: Basal Cell Carcinoma

In brief

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

Key facts

Study ID

NCT02120677

Run by

Johns Hopkins University

People needed

5

Starts

2014-05-01

Expected to finish

2019-01-30

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Johns Hopkins School of Medicine, Department of Dermatology — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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