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Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

This study has been completed.
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University Identifier:
First received: April 19, 2010
Last updated: June 30, 2016
Last verified: June 2016

BCCs are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

We hope to learn if an oral antifungal drug, Itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

Thus, it may reduce BCC growth in humans.

Condition Intervention Phase
Skin Cancers
Carcinoma, Basal Cell
Skin Cancer
Basal Cell Carcinoma
Drug: Itraconazole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients With Basal Cell Carcinomas

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • oral or topical Itraconazole reduction of Basal Cell Carcinomas biomarkers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Topical Itraconazole penetration Basal Cell Carcinomas tumors. [ Time Frame: after 2-3 weeks of topical (400mg daily) vs. oral Itraconazole (400 mg daily) ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole 200 mg twice daily
200 mg twice daily; oral
Drug: Itraconazole
200 mg twice daily; oral
Other Name: Sporanox


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • At least one BCC tumor (greater than 4mm in diameter) at any skin location, to be biopsied and surgically removed.
  • Had at least one liver function test (AST, ALT) with normal results in the last year.
  • Willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC
  • Consent to research use of their BCC tissue.


  • History or current hepatitis or other liver disease.
  • Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids)
  • History or current evidence of malabsorption or liver disease within the one year prior to enrollment.
  • History or current evidence of hyperthyroidism increasing metabolism of itraconazole
  • Unable to attend to 2nd study visit at Stanford for MOHS surgical excision
  • Current immunosuppression disease (cancer, autoimmune disease)
  • Receiving immunosuppressive drugs
  • Pregnant
  • Lactating
  • Any female actively trying to become pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT01108094

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Jean Y Tang, MD Stanford University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University Identifier: NCT01108094     History of Changes
Other Study ID Numbers: SKIN0004-TX  SU-04162010-5722  17365 
Study First Received: April 19, 2010
Last Updated: June 30, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on October 26, 2016