NCT02735356

Topical Itraconazole in Treating Patients With Basal Cell Cancer

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Jean Yuh Tang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Skin Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Itraconazole	Applied topically
OTHER	Placebo	Applied topically

Timeline

• Start date: 2016-05-05
• Primary completion: 2017-09-19
• Completion: 2017-10-10
• First posted: 2016-04-12
• Last updated: 2019-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study