Clinical trial NCT02120677: Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Official title: A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Basal Cell Carcinoma
Keywords: skin cancer
basal cell carcinoma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Downregulation in glucagon-like immunoreactivity (GLI) expression
timeFrame: Day 8
Secondary outcomes:
measure: Incidence, timing, and severity of treatment adverse events
timeFrame: 45 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine, Department of Dermatology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nikki Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: