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CompletedNCT02735356Updated Apr 11, 2019

Topical Itraconazole in Treating Patients With Basal Cell Cancer

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

From the registry’s dates

  • Primary completion was Sep 2017, 9 years ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Basal Cell Carcinoma
03

In context

Carcinoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Treatment (itraconazole and placebo)

    Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.

    Drug: Itraconazole · Other: Placebo

Interventions

  • DrugItraconazole

    Applied topically

    Also known as: Lozanoc, Oriconazole, R 51,211, Sporanox

  • OtherPlacebo

    Applied topically

    Also known as: placebo therapy, PLCB, sham therapy

06

What researchers measure

Primary outcomes

  1. Percentage change of GLi levels in treated vs untreated tumors

    will be assessed as relative GLi1 mRNA expression

    Time frame: Up to 1 month

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Stanford Cancer Institute
    Palo Alto, California 94304, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02735356
Lead sponsor
Jean Yuh Tang
Collaborators
National Cancer Institute (NCI)
Responsible party
Jean Yuh Tang (Associate Professor of Dermatology, Stanford University) — Sponsor-investigator
First posted
Apr 12, 2016
Start date
May 5, 2016
Primary completion
Sep 19, 2017
Completion
Oct 10, 2017
Last update
Apr 11, 2019

Study contacts

Anthony Oro
principal investigator · Stanford Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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