Topical Itraconazole in Treating Patients With Basal Cell Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-05

Study Completion Date

2017-10-10

Brief Summary

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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.

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Detailed Description

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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

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Skin Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (itraconazole and placebo)

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

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Applied topically

Placebo

Intervention Type OTHER

Applied topically

Interventions

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Itraconazole

Applied topically

Intervention Type DRUG

Placebo

Applied topically

Intervention Type OTHER

Other Intervention Names

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Lozanoc Oriconazole R 51,211 Sporanox placebo therapy PLCB sham therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No