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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567149
Recruitment Status : Withdrawn (No funding)
First Posted : October 2, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Warts Drug: Cidofovir Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
Drug Information available for: Cidofovir

Arm Intervention/treatment
Experimental: Cidofovir
Cidofovir clinical resolution of treated warts as evaluated by the investigators
Drug: Cidofovir
Cidofovir




Primary Outcome Measures :
  1. 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

  2. Improvement of wart-associated symptoms [ Time Frame: 6 months ]
    2. Patient-perceived improvement of wart-associated symptoms


Secondary Outcome Measures :
  1. Patient/parent reported tolerability of the treatment [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Primary immunodeficiency, which may include but is not limited to the following:

      1. Chronic Granulomatous Disease (CGD)
      2. Common Variable Immunodeficiency (CVID)
      3. DiGeorge Syndrome (DGS)
      4. Selective IgA Deficiency
      5. Severe Combined Immunodeficiency (SCID)
      6. X-Linked Agammaglobulinemia (XLA)
    2. Pharmacologic immune-suppressed status from medications including but not limited to:

      1. prednisone
      2. cyclosporine
      3. azathioprine
      4. tacrolimus/ FK506
      5. mycophenolate mofetil
      6. 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:

    1. Treatment area is either ulcerated, secondarily infected, or significantly inflamed
    2. Treatment area is on face or groin area
    3. Patient is pregnant, attempting to become pregnant, or lactating
    4. 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
    5. Patient is currently receiving a nephrotoxic medication
    6. Patient has history of hypersensitivity to cidofovir
    7. Patient is severely ill and/or hospitalized
    8. Patient is receiving chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567149


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Ingrid Polcari, MD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02567149    
Other Study ID Numbers: Version 1.0
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Wart
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Cidofovir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action