Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Resolution
研究概览
简要总结
Warts are common, benign skin lesions caused by the human papillomavirus (HPV). Treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. Existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date informed consent and assent for minors.
- •Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the screening assessments and medical history.
- •Diagnosis of warts on the hands
- •Wart count on the hands and 3-10
排除标准
- •Wart duration >2 years.
- •More than 10 warts in non-hand areas.
- •Total wart surface area on the hands bigger than 100 cm2
- •Prior treatment failure with the following modalities:
- •1. intralesional immunotherapy
- •intralesional bleomycin, 5-fluorouracil, methotrexate
- •intralesional cidofovir
- •Any over the counter, prescription topical, or in-office procedural wart treatment within 6 weeks of baseline (Day 1)
- •Known immuno-suppressed state due to disease or medication, medical treatment o
- •Known allergy to any component of the IP
- •Any conditions that, in the Principal Investigator's opinion, may interfere with the course of the study
研究组 & 干预措施
Topical treatment arm
Topical medication self-applied
干预措施: Tirbanibulin ointment 1% (Drug)
结局指标
主要结局
Resolution
时间窗: 2 months aftre completion of 4 or less treatment cycles
Ful resolution of treated lesions
次要结局
未报告次要终点
研究者
Dr. Peter C. Friedman
Principal Investigator
The Skin Center Dermatology Group