Hydroxychloroquine Efficacy in Chronic Urticaria

Vanderbilt University

Status: Withdrawn

Conditions: Chronic Urticaria

Treatments: Drug: Hydroxychloroquine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01073852

Pending

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients will be taking placebo medication throughout study.

Treatment:

Drug: Placebo

Hydroxychloroquine

Active Comparator group

Description:

Patients will be taking hydroxychloroquine throughout study.

Treatment:

Drug: Hydroxychloroquine