Hydroxychloroquine Efficacy in Chronic Urticaria

January 21, 2013 updated by: John Michael Fahrenholz, Vanderbilt University

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients will be taking placebo medication throughout study.
Drug: Placebo
Placebo pill, 1 pill orally twice daily for 9 weeks.
Active Comparator: Hydroxychloroquine
Patients will be taking hydroxychloroquine throughout study.
Drug: Hydroxychloroquine
Patients will be taking hydroxychloroquine 200mg orally twice/daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urticarial Symptom Score
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in Basophil Activation
Time Frame: 10 weeks
10 weeks
Difference in Rescue Medication Usage
Time Frame: 10 weeks
10 weeks
Difference in Dermatology Life Quality Index
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Pogie Pongonis, MD, Vanderbilt University
  • Study Director: John Fahrenholz, MD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending (Other Identifier: Pending)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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