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

Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02567149
• Other study ID #: Version 1.0
• Status: Withdrawn
• Phase: Phase 2
• First received: September 30, 2015
• Last updated: June 28, 2017
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Warts

Intervention

Drug:
• Cidofovir
Cidofovir

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Improvement of wart-associated symptoms	2. Patient-perceived improvement of wart-associated symptoms	6 months
Secondary	Patient/parent reported tolerability of the treatment		6 months