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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hydroxychloroquine Efficacy in Chronic Urticaria|
- Urticarial Symptom Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Difference in Basophil Activation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Difference in Rescue Medication Usage [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Difference in Dermatology Life Quality Index [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Patients will be taking placebo medication throughout study.
Placebo pill, 1 pill orally twice daily for 9 weeks.
Active Comparator: Hydroxychloroquine
Patients will be taking hydroxychloroquine throughout study.
Patients will be taking hydroxychloroquine 200mg orally twice/daily.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073852
|Principal Investigator:||Pogie Pongonis, MD||Vanderbilt University|
|Study Director:||John Fahrenholz, MD||Vanderbilt University|