Chronic Urticaria Clinical Trial
Official title:
Hydroxychloroquine Efficacy in Chronic Urticaria
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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