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临床试验/NCT04253912
NCT04253912Unknown2 期

A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris

Veloce BioPharma LLC1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年2月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
90
试验地点
1
主要终点
Decrease in wart diameter (mm)

研究概览

简要总结

This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 verruca vulgaris (common warts).
  • Subject has up to 6 warts located on the trunk or extremities

排除标准

  • Subject has clinically atypical warts on the trunk or extremities.
  • Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
  • Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.

研究组 & 干预措施

VBP-245

Experimental

Topical 2% Povidone-Iodine Gel

干预措施: VBP-245 (Drug)

Control

Placebo Comparator

Placebo Gel (no Povidone-Iodine)

干预措施: Placebo Gel (no Povidone-Iodine) (Drug)

结局指标

主要结局

Decrease in wart diameter (mm)

时间窗: 12 weeks

次要结局

  • Resolution of wart(12 weeks)
  • Application Site Reaction Adverse Events(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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