Clinical trial NCT01073852: Hydroxychloroquine Efficacy in Chronic Urticaria
Official title: Hydroxychloroquine Efficacy in Chronic Urticaria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Urticaria
Keywords: Chronic Urticaria
Hives
Hydroxychloroquine
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Inclusion:

  1. Age \>18, Age\<65
  2. Chronic Urticaria refractory to treatment with standard anti-histamines
  3. Minimum Urticaria Score

Exclusion Criteria:

* Exclusion:

  1. Pregnancy
  2. Vasculitis
  3. Trigger Induced Urticaria
  4. Food intolerance
  5. Malignancy
  6. Kidney or liver dysfunction
  7. Systemic diseases
  8. Hypersensitivity to hydroxychloroquine

Primary outcomes:
measure: Urticarial Symptom Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Difference in Basophil Activation
timeFrame: 10 weeks
measure: Difference in Rescue Medication Usage
timeFrame: 10 weeks
measure: Difference in Dermatology Life Quality Index
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Pogie Pongonis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: John Fahrenholz, MD
role: STUDY_DIRECTOR
References:
citation: Reeves GE, Boyle MJ, Bonfield J, Dobson P, Loewenthal M. Impact of hydroxychloroquine therapy on chronic urticaria: chronic autoimmune urticaria study and evaluation. Intern Med J. 2004 Apr;34(4):182-6. doi: 10.1111/j.1444-0903.2004.00532.x.