Hydroxychloroquine Efficacy in Chronic Urticaria
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Urticarial Symptom Score
研究概览
简要总结
This study is for those people with difficult to treat hives. We are investigating whether or not a different medication, hydroxychloroquine, works to treat a certain type of hives. Hydrochloroquine is currently approved by the Food and Drug Administration (FDA), for treating arthritis, therefore it is considered investigational in this study.
Hypothesis: Hydroxychloroquine will prove to have an efficacious response in terms of Urticarial Symptoms, on patients with chronic urticaria.
详细描述
Our research question is: Is hydroxychloroquine an efficacious medicine to use in patients with chronic urticaria? Answering this question should help allergists treat chronic urticaria with a more evidence based approach. To date there has one been one prospective trial evaluating hydroxychloroquine in hives, and although it showed a trend towards efficacy (0.05<p<0.10), it was not statistically significant. There have been case series, and anecdotal reports which seem to demonstrate efficacy of chloroquine in chronic urticaria. Because of these reports hydroxychloroquine is often the first medication used in patients with chronic hives that are refractory to standard therapy of antihistamines. We believe an evidence based answer to this question will be an important step towards improved treatment of this disease.
We plan to ascertain the efficacy of hydroxychloroquine by completing a randomized double blinded placebo controlled study of treatment in patients with chronic urticaria. We will be measuring an Urticarial Score to evaluate hive symptoms. We will be measuring them at baseline, and at the end of the study to note change in drug vs placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion:
- •Age >18, Age<65
- •Chronic Urticaria refractory to treatment with standard anti-histamines
- •Minimum Urticaria Score
排除标准
- •Exclusion:
- •Trigger Induced Urticaria
- •Food intolerance
- •Kidney or liver dysfunction
- •Systemic diseases
- •Hypersensitivity to hydroxychloroquine
研究组 & 干预措施
Placebo
Patients will be taking placebo medication throughout study.
干预措施: Placebo (Drug)
Hydroxychloroquine
Patients will be taking hydroxychloroquine throughout study.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Urticarial Symptom Score
时间窗: 10 weeks
次要结局
- Difference in Basophil Activation(10 weeks)
- Difference in Rescue Medication Usage(10 weeks)
- Difference in Dermatology Life Quality Index(10 weeks)
研究者
John Michael Fahrenholz
MD
Vanderbilt University