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

• Sponsor: University of Minnesota (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02567149
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical resolution of treated warts as evaluated by the investigators [6 months]

   Total or near-total clinical resolution of treated warts as evaluated by the investigators

2. Improvement of wart-associated symptoms [6 months]

   2. Patient-perceived improvement of wart-associated symptoms

Secondary Outcome Measures

1. Patient/parent reported tolerability of the treatment [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

2. Chronic Granulomatous Disease (CGD)

3. Common Variable Immunodeficiency (CVID)

4. DiGeorge Syndrome (DGS)

5. Selective IgA Deficiency

6. Severe Combined Immunodeficiency (SCID)

7. X-Linked Agammaglobulinemia (XLA)

8. Pharmacologic immune-suppressed status from medications including but not limited to:

9. prednisone

10. cyclosporine

11. azathioprine

12. tacrolimus/ FK506

13. mycophenolate mofetil

14. sirolimus

15. 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.

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02567149
• Other Study ID Numbers: Version 1.0
• First Posted: Oct 2, 2015
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Warts; Cidofovir

Study Results

No Results Posted as of Jul 2, 2017