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Not Recruiting
Trial ID: NCT02735356
A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
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
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061