Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical resolution of treated warts as evaluated by the investigators
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first cohort will include a total of 4 patients ages 12 to
- •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:
- •cyclosporine
- •azathioprine
- •tacrolimus/ FK506
- •mycophenolate mofetil
- •Patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable
- •Patient has a total wart burden of at least 1cm
- •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
- •Patient and/or their parent/guardian consents to participating in this study
排除标准
- •Treatment area is either ulcerated, secondarily infected, or significantly inflamed
- •Treatment area is on face or groin area
- •Patient is pregnant, attempting to become pregnant, or lactating
- •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
- •Patient is currently receiving a nephrotoxic medication
- •Patient has history of hypersensitivity to cidofovir
- •Patient is severely ill and/or hospitalized
- •Patient is receiving chemotherapy
研究组 & 干预措施
Cidofovir
Cidofovir clinical resolution of treated warts as evaluated by the investigators
干预措施: Cidofovir (Drug)
结局指标
主要结局
Clinical resolution of treated warts as evaluated by the investigators
时间窗: 6 months
Total or near-total clinical resolution of treated warts as evaluated by the investigators
Improvement of wart-associated symptoms
时间窗: 6 months
2. Patient-perceived improvement of wart-associated symptoms
次要结局
- Patient/parent reported tolerability of the treatment(6 months)