An Early Phase 1 interventional study of Itraconazole and Placebo in Skin Basal Cell Carcinoma, sponsored by Jean Yuh Tang. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-11.
Sponsored by Jean Yuh Tang · Early Phase 1, Interventional, and Treatment
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.
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:
Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
After completion of study treatment, patients are followed up for up to 14 weeks.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Jean Yuh Tang is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
Drug: Itraconazole · Other: Placebo
Applied topically
Also known as: Lozanoc, Oriconazole, R 51,211, Sporanox
Applied topically
Also known as: placebo therapy, PLCB, sham therapy
Percentage change of GLi levels in treated vs untreated tumors
will be assessed as relative GLi1 mRNA expression
Time frame: Up to 1 month
Change in BCC tumor size
Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).
Time frame: At baseline, 1, 4, and 12 weeks
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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