A Multi-center, Randomized, Double-blind, Vehicle-controlled, Phase-2 Trial to Evaluate the Efficacy and Safety of Two Concentrations of VBP-926 Solution for the Treatment of Chemotherapy-associated Paronychia in Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 8
- 主要终点
- Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
研究概览
简要总结
Paronychia is inflammation of the skin surrounding the nail that leads to secondary infection. Iatrogenic paronychia has been clearly associated with cancer chemotherapies. This phase-2 trial is a dose finding study and will evaluate topical VBP-926 solution against a vehicle control.
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
The randomization will be done centrally by a randomization programmer/statistician who will be the only un-blinded participant. That person will not have any part in the decisions regarding patient populations and/or protocol violations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 years or older
- •Acute paronychia developing during the course of their monotherapy or combination chemotherapy
- •Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
- •Eastern Cooperative Oncology Group score ≤ 2
- •Life expectancy of at least 12 months as per the investigator's judgment
- •Willing to provide written informed consent
- •Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
- •Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
- •Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
排除标准
- •Mentally incompetent or unable or not willing to give written informed consent or meet study requirements
- •Without a history of a cancer diagnosis
- •Without history of cancer diagnosis using chemotherapy
- •Patients with paronychia requiring surgical intervention at baseline
- •Patients who are already on prescribed treatment for paronychia who are not willing to discontinue this treatment and only use study drug (no washout period required)
- •Neutropenia (absolute neutrophil count < 1500 cells/µL)
- •Patient Human Immunodeficiency Virus (HIV) infection
- •Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
- •Have any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk
研究组 & 干预措施
Lower concentration VBP-926
VBP-926 solution applied to affected area BID
干预措施: VBP-926 (Drug)
Higher concentration VBP-926
VBP-926 solution applied to affected area BID
干预措施: VBP-926 (Drug)
Vehicle
Vehicle solution applied to affected area BID
干预措施: VBP-926 (Drug)
结局指标
主要结局
Downgrading of the 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) in adult cancer patients with chemotherapy-associated paronychia
时间窗: 8 weeks
Treatment responses will be assessed by clinical grading utilizing a morphologic 6-point Paronychia Severity Grading scale (adapted from CTCAE v4.0) and will be assessed from baseline to 8 weeks for each affected nail.
次要结局
未报告次要终点