Clinical trial · Interventional
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
NCT02735356CI-TRIAL-00038077completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Basal Cell Carcinoma | Skin Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (itraconazole and placebo)
- description
- Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.
- interventionNames
- Drug: Itraconazole
- Other: Placebo
Primary outcomes (1)
- measure
- Percentage change of GLi levels in treated vs untreated tumors
- timeFrame
- Up to 1 month
- description
- will be assessed as relative GLi1 mRNA expression
Secondary outcomes (1)
- measure
- Change in BCC tumor size
- timeFrame
- At baseline, 1, 4, and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.