Topical Itraconazole in the Treatment of Basal Cell Carcinoma

NCT02120677 | Completed Early Phase 1 DMC

• 1 other identifier: NA_00077461
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.

Conditions

Basal Cell Carcinoma

Keywords

skin cancer; basal cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Downregulation in glucagon-like immunoreactivity (GLI) expression

  We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.

  Day 8

Secondary Outcomes (1)

• Incidence, timing, and severity of treatment adverse events

  45 days

Study Arms (1)

Itraconazole ointment

EXPERIMENTAL

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.

Drug: Itraconazole

Interventions

Itraconazole DRUG

Itraconazole comes in the form of capsules and liquid (oral solution). It is FDA approved for treatment of systemic Blastomycosis, Histoplasmosis and Aspergillosis in immunocompromised and non-immunocompromised patients at doses ranging from 200mg to 400mg daily. The current FDA approved dosage recommendation for treating toenail onychomycosis (nail fungus) is 200mg PO per day for 3 months. Test materials in this study will be prepared as an ointment (compounded in petrolatum jelly).

Also known as: Sporanox

Itraconazole ointment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine, Department of Dermatology

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Nikki Tang, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 23, 2014
• Study Start: May 1, 2014
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)