Clinical trial · Interventional
Topical Itraconazole in the Treatment of Basal Cell Carcinoma
A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
NCT02120677CI-TRIAL-00048839completedEarly 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 research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.
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 |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Itraconazole ointment
- description
- Patients with histologically proven BCC will be eligible for study enrollment. 50% itraconazole compounded in petrolatum jelly will be applied under occlusion for up to 3 to 7 days.
- interventionNames
- Drug: Itraconazole
Primary outcomes (1)
- measure
- Downregulation in glucagon-like immunoreactivity (GLI) expression
- timeFrame
- Day 8
- description
- We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
Secondary outcomes (1)
- measure
- Incidence, timing, and severity of treatment adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be over the age of 18 years * Male * Women who do not have child-bearing potential (history of hysterectomy, post-menopausal) * Have a biopsy confirmed BCC that measures at least 6mm in size at the time of the initial evaluation (visit #1); * Participant must be willing and comply with the requirements of the protocol; * Participant must have the ability to understand and communicate with the investigator; * Participant must provide informed consent. Exclusion Criteria: * Subject with significant congestive heart failure (CHF) or history of CHF, chronic renal failure, hepatic failure, neuropathy * Subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous T-cell lymphoma, erythroderma; * Subjects on systemic medications known to affect the Hedgehog pathway (see Appendix I) * Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine * Subjects with history of hypersensitivity to azoles * Subjects with Gorlin syndrome * Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers) * Subjects who do not speak English or have difficulty hearing or are otherwise impaired for providing informed consent and communicating with the investigator; * Subjects with a history of keloids or excessive scarring; * Subjects with known allergy to lidocaine, epinephrine, itraconazole or petrolatum * Women of child-bearing age/potential and/or able to conceive
References
Publications (0)
Data not yet available
No reference posted for this study.