Hydroxychloroquine Efficacy in Chronic Urticaria

Not Applicable

Withdrawn

• Conditions: Chronic Urticaria
• Interventions: Drug: Placebo; Drug: Hydroxychloroquine

• Registration Number: NCT01073852
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will be taking placebo medication throughout study.
Hydroxychloroquine	Hydroxychloroquine	Patients will be taking hydroxychloroquine throughout study.

Primary Outcome Measures

Name	Time	Method
Urticarial Symptom Score	10 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in Basophil Activation	10 weeks
Difference in Rescue Medication Usage	10 weeks
Difference in Dermatology Life Quality Index	10 weeks