NCT05057663Unknown不适用
Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
研究概览
简要总结
Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be considered for participation in this study.
- •Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- •Male or female ≥ 8 years old.
- •Subject has a clinical diagnosis of common warts.
- •Subject has up to 1 Target Wart and up to 3 additional Non-Target Warts located on the trunk or extremities. The identified Target and Non-Target Warts must meet the requirements as defined below:
- •Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm
- •Each wart must be a discrete lesion
- •Each wart must be present for at least 4 weeks
- •Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
- •Not be in an intertriginous fold
- •Be the only common wart present when the circular cutout template is centered over the wart
- •The Target and Non-Target Warts must have a PWA ≥
- •Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
- •Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
- •Subject is non-pregnant and non-lactating.
- •Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target or Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
- •Subject is willing and able to follow all study instructions and to attend all study visits.
排除标准
- •Subjects are excluded from this study if any 1 or more of the following criteria is met:
- •Subject has clinically atypical warts on the trunk or extremities.
- •Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant
研究组 & 干预措施
Bleomycin group
Active Comparator
干预措施: Bleomycin and 5-fluorouracil (Drug)
5-Fluorouracil group
Active Comparator
干预措施: Bleomycin and 5-fluorouracil (Drug)
结局指标
主要结局
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
时间窗: 3monthes
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated 1. Near Clear: A visible wart that is less than 3mm in maximal diameter (or length) 2. A visible wart ≥ 3mm and \<6 mm in maximal diameter (or length) 3. A visible wart ≥ 6mm in maximal diameter (or length)
次要结局
未报告次要终点
研究者
Rania Farouk Daif
Director, Head of Dermatology, Andrology and Venerology, Principal investigator, clinical professor
Sohag University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Comparative efficacy of intralesional bleomycin sulphate and intra-lesional Immunotherapy with Candida skin testing antigen in the treatment of palmoplantar warts.CTRI/2018/01/011524INDIAN COUNCIL OF MEDICAL RESEARCH
尚未招募
不适用
Comparison Between Diode Laser and Bleomycin in Treatment of HemangiomaBleomycin Adverse ReactionNCT06510829Assiut University30
Unknown
4 期
The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar WartsWartsNCT03477448Assiut University40
招募中
3 期
ewer treatment modality for chalazion a benign lid swellingCTRI/2022/06/043117Sadguru Netra Chikitsalya
招募中
1 期
Role of bleomycin injection in vascular lesions around the eyeCTRI/2020/07/026862RP Centre