Back to resultsTopical Itraconazole in the Treatment of Basal Cell Carcinoma
Primary Purpose
Basal Cell Carcinoma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Itraconazole
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring skin cancer, basal cell carcinoma
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Itraconazole ointment
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence, timing, and severity of treatment adverse events
Data on adverse events will be collected and reported by treatment cohort and overall.
Full Information
NCT ID
NCT02120677
First Posted
April 21, 2014
Last Updated
December 14, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02120677
Brief Title
Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Official Title
A Pilot Study Investigating Antitumorigenic Potential of Topical Itraconazole in the Treatment of Basal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research is being done to study the molecular effects of topically applied itraconazole ointment on the growth of basal cell carcinomas.
Detailed Description
Basal cell carcinoma is the most common type of skin cancer in Caucasians worldwide. Although rarely metastatic, it can be locally destructive causing disfigurement and pain. Current therapies include surgical removal, local destruction, radiotherapy and others.
Advances in understanding the molecular basis behind BCCs indicate that mutations in the hedgehog signaling pathway can lead to the development of many sporadically occurring basal cell carcinomas (BCCs). An oral drug that targets the hedgehog signaling pathway has been shown to be effective in treating patients with metastatic and inoperable BCCs. There is evidence that itraconazole, a commonly prescribed antifungal medication may also affect this pathway. It is not known whether itraconazole ointment applied topically can affect the growth of BCCs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
skin cancer, basal cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itraconazole ointment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
Sporanox
Intervention Description
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).
Primary Outcome Measure Information:
Title
Downregulation in glucagon-like immunoreactivity (GLI) expression
Description
We will report the proportion of patients by treatment cohort and overall that had a significant downregulation in GLI.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Incidence, timing, and severity of treatment adverse events
Description
Data on adverse events will be collected and reported by treatment cohort and overall.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikki Tang, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine, Department of Dermatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Itraconazole in the Treatment of Basal Cell Carcinoma
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