NCT02735356CompletedEarly Phase 1
A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
Jean Yuh Tang1 site in 1 country9 target enrollmentStarted: May 5, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Percentage change of GLi levels in treated vs untreated tumors
Study Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
SECONDARY OBJECTIVES:
I. To determine if topical itraconazole gel will decrease BCC size.
OUTLINE:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment (itraconazole and placebo)
Experimental
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Intervention: Itraconazole (Drug)
Treatment (itraconazole and placebo)
Experimental
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Percentage change of GLi levels in treated vs untreated tumors
Time Frame: Up to 1 month
will be assessed as relative GLi1 mRNA expression
Secondary Outcomes
- Change in BCC tumor size(At baseline, 1, 4, and 12 weeks)
Investigators
Jean Yuh Tang
Associate Professor of Dermatology
Stanford University
Study Sites (1)
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