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

June 28, 2017 updated by: University of Minnesota

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

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

    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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ingrid Polcari, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Warts

Clinical Trials on Cidofovir

3
Subscribe