Topical Itraconazole in the Treatment of Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02120677|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Drug: Itraconazole||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 30, 2019|
|Actual Study Completion Date :||January 30, 2019|
Experimental: Itraconazole ointment
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.
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).
Other Name: Sporanox
- Downregulation in glucagon-like immunoreactivity (GLI) expression [ Time Frame: Day 8 ]We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
- Incidence, timing, and severity of treatment adverse events [ Time Frame: 45 days ]Data on adverse events will be collected and reported by treatment cohort and overall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120677
|United States, Maryland|
|Johns Hopkins School of Medicine, Department of Dermatology|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Nikki Tang, MD||Johns Hopkins University|