Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.

Study Overview
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Brief Summary
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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

Detailed Description
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This study includes pediatric patients with history of either primary or iatrogenic immune-suppression who are seeking treatment of warts that have already proven recalcitrant to standard therapy. The first cohort will include 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.

Official Title
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Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.

Conditions
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Warts

Intervention / Treatment
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* Drug: Cidofovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cidofovir<br>Cidofovir clinical resolution of treated warts as evaluated by the investigators | Drug: Cidofovir<br>* Cidofovir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical resolution of treated warts as evaluated by the investigators | Total or near-total clinical resolution of treated warts as evaluated by the investigators | 6 months | 
| Improvement of wart-associated symptoms | 2. Patient-perceived improvement of wart-associated symptoms | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient/parent reported tolerability of the treatment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wart