A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin for the Treatment of Common Warts (Verruca Vulgaris) in Adolescents and Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 18
- 主要终点
- Number of participants with complete resolution of the treatment wart
研究概览
简要总结
The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:
- does treatment with Candin result in better clearance of warts than placebo
- how many injections are required to result in wart clearance Participants will
- have one wart selected for injection every two weeks until clearance
- return 12 weeks after wart clearance for assessment of durability of response
详细描述
This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.
Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.
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)
盲法说明
Unblinded site staff will prepare syringes of study drug for administration by blinded study staff
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3, but not more than 20 common warts (Verruca vulgaris)
- •Willing to agree to use adequate contraception methods during the study
排除标准
- •Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function
- •Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at the Baseline Visit
- •History of keloid formation
- •Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment
- •Treatment with immunotherapy (e.g., diphenylcyclopropenone [DPCP], dinitrochlorobenzene [DNCB], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study
- •Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study
- •Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids [topical or inhaled steroids are acceptable]).
- •Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study
研究组 & 干预措施
Candin treatment
Candida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections
干预措施: Candin, Intradermal Solution (Drug)
Placebo
Matching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with complete resolution of the treatment wart
时间窗: Twelve weeks after last injection
Absence of visual or measurable wart maintained through the entire Observational Period for injected wart
次要结局
- Time to wart clearance(Up to 27 weeks)
- Number of participants with clinical clearance of at least 50% of all measured warts(Up to 27 weeks)
- Number of participants with clinical clearance of all measured warts(Up to 27 weeks)
- Time to clinical clearance of all measured warts(Up to 27 weeks)