- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02567149
Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
The primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy.
The secondary objective is to determine the tolerability of this new mode of administration of cidofovir in the pediatric population
Study Overview
Detailed Description
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. The first cohort will include a total of 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.Patient is in immune-suppressed status by one of the following:
Primary immunodeficiency, which may include but is not limited to the following:
- Chronic Granulomatous Disease (CGD)
- Common Variable Immunodeficiency (CVID)
- DiGeorge Syndrome (DGS)
- Selective IgA Deficiency
- Severe Combined Immunodeficiency (SCID)
- X-Linked Agammaglobulinemia (XLA)
Pharmacologic immune-suppressed status from medications including but not limited to:
- prednisone
- cyclosporine
- azathioprine
- tacrolimus/ FK506
- mycophenolate mofetil
- sirolimus
2. Patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable 3. Patient has a total wart burden of at least 1cm 4. Patients must have tried and failed at least 2 other conventional treatments for cutaneous warts, including but not limited to:
- cryotherapy
- topical salicylic acid
- imiquimod
- topical 5FU
- pulsed dye laser therapy
- sinecatechins
- tretinoin or other topical retinoid
- intralesional candida injection
- bleomycin
- electrocautery
- topical cidofovir cream or gel
There will be a one month washout period for all treatment modalities, with the exception of intralesional candida, which will be 3 months.
5. Patient desires ongoing treatment of their warts 6. Patient and/or their parent/guardian consents to participating in this study
Exclusion Criteria:
- Treatment area is either ulcerated, secondarily infected, or significantly inflamed
- Treatment area is on face or groin area
- Patient is pregnant, attempting to become pregnant, or lactating
- Patient reports active kidney disease, or chart review reveals recent serum creatinine ≥1.5mg/dL or a history of renal disease/insufficiency or history of diabetes
- Patient is currently receiving a nephrotoxic medication
- Patient has history of hypersensitivity to cidofovir
- Patient is severely ill and/or hospitalized
- Patient is receiving chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cidofovir
Cidofovir clinical resolution of treated warts as evaluated by the investigators
|
Cidofovir
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical resolution of treated warts as evaluated by the investigators
Time Frame: 6 months
|
Total or near-total clinical resolution of treated warts as evaluated by the investigators
|
6 months
|
Improvement of wart-associated symptoms
Time Frame: 6 months
|
2. Patient-perceived improvement of wart-associated symptoms
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient/parent reported tolerability of the treatment
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ingrid Polcari, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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