Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-02 @ 9:00 AM
Study NCT ID:
NCT02735356
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Itraconazole in Treating Patients With Basal Cell Cancer
Sponsor:
Jean Yuh Tang
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-00452 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| SKIN0030 | OTHER | OnCore | View | |
| P30CA124435 | NIH | None | https://reporter.nih.gov/quic… | View |