Topical Itraconazole in Treating Patients With Basal Cell Cancer

Not Recruiting

Trial ID: NCT02735356


This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.

Official Title

A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients

Stanford Investigator(s)

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor


Inclusion Criteria:

   - The subject must sign and date all informed consent statements; children will sign the
   assent form and their guardian will sign the consent form

   - The subject must be willing to apply the medications twice daily for 1 month

   - The subjects must have at least four BCCs in non-cosmetically sensitive sites

   - For women of child-bearing potential, a negative urine pregnancy test

   - Women of child-bearing potential are expected to use an effective method of birth
   control to prevent exposing a fetus to potentially dangerous agent with unknown risk

   - For male patients with female partners of childbearing potential, agreement to use
   adequate contraception while you are participating in the study and 1 month after
   applying your last dose

Exclusion Criteria:

   - Pregnancy or breast-feeding

   - History of congestive heart failure or other findings of ventricular dysfunction

   - History of current evidence of malabsorption or liver disease

   - Current immunosuppression or taking immunosuppressive drugs

   - Taking oral itraconazole

   - Taking any medication known to affect hedgehog (HH) signaling pathway

   - The subject has used topical or systemic therapies that might interfere with the
   evaluation of the study medication during the study; specifically these include the
   topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate,
   isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii)
   alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin
   during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also -
   treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling
   within 60 days to starting study medication


drug: Itraconazole

other: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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