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

Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
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• 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

⁃ 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.

⁃ Patient desires ongoing treatment of their warts 6. Patient and/or their parent/guardian consents to participating in this study

Locations
United States
Minnesota
University of Minnesota Medical Center
Minneapolis
Time Frame
Start Date: 2016-06
Completion Date: 2016-06
Treatments
Experimental: Cidofovir
Cidofovir clinical resolution of treated warts as evaluated by the investigators
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov