An Early Phase 1 interventional study of Itraconazole in Basal Cell Carcinoma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Treatment
This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 5 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Itraconazole
Itraconazole comes in the form of capsules and liquid (oral solution). It is FDA approved for treatment of systemic Blastomycosis, Histoplasmosis and Aspergillosis in immunocompromised and non-immunocompromised patients at doses ranging from 200mg to 400mg daily. The current FDA approved dosage recommendation for treating toenail onychomycosis (nail fungus) is 200mg PO per day for 3 months. Test materials in this study will be prepared as an ointment (compounded in petrolatum jelly).
Also known as: Sporanox
Downregulation in glucagon-like immunoreactivity (GLI) expression
We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
Time frame: Day 8
Incidence, timing, and severity of treatment adverse events
Data on adverse events will be collected and reported by treatment cohort and overall.
Time frame: 45 days
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University