NCT04492618已完成2 期
Ruxolitinib Cream in the Treatment of Cutaneous Necrobiosis Lipoidica
Aaron R. Mangold1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Mean Necrobiosis Lipoidica (NL) Lesion Score
研究概览
简要总结
This research study is evaluating the safety and efficacy of a topical drug treatment "Ruxolitinib" in treating Necrobiosis Lipoidica (NL).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation
- •Both men and women must be at least 18 years of age at the time of screening
- •Subjects must have clinical and histological features of NL
- •Subjects must have at least one NL lesion measuring at least 1.7 cm
- •NL must not affect greater than 10% BSA
排除标准
- •On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy (Table-1).
- •Known hypersensitivity to Ruxolitinib formulation.
- •Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).
- •Women of childbearing potential [Post-menopausal or not of child-bearing potential is defined by: 1 year of natural (spontaneous) amenorrhea or Surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. Oophorectomy alone must be confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using medically acceptable methods of contraception which includes:
- •Total abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception).
- •Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. Oophorectomy alone requires follow up hormone level assessment for fertility.
- •Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
- •Barrier methods of contraception: condom or occlusive cap.
- •Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure <1%). (The dose of the contraceptive should be stable for 3 months).
- •Active ongoing inflammatory diseases of the skin other than NL that might confound the evaluation of the benefit of ruxolitinib cream.
- •Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromised the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
- •Active systemic infections during the 2 weeks prior to randomization (common cold viruses not included) or any infection that reoccurs on a regular basis.
- •Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
研究组 & 干预措施
Necrobiosis Lipoidica
Experimental
Adults with cutaneous Necrobiosis Lipoidica (NL) up to 10% of the body surface area (BSA) treated with Ruxolitinib cream
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Change in Mean Necrobiosis Lipoidica (NL) Lesion Score
时间窗: Baseline, week 12
The NL skin scoring system examines the index treatment lesion on a scale from 0 (none) to 3 (severe) for each of the following areas: erythema, infiltration, ulceration, and pain. A total possible score of 0-12, with lower scores indicating none and higher scores indicating more severe.
次要结局
未报告次要终点
研究者
Aaron R. Mangold
Principal Investigator
Mayo Clinic
研究点 (1)
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