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Hydroxychloroquine Efficacy in Chronic Urticaria

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ClinicalTrials.gov Identifier: NCT01073852
Recruitment Status : Withdrawn (withdrawn, not funded)
First Posted : February 23, 2010
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Chronic Urticaria Drug: Placebo Drug: Hydroxychloroquine

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Efficacy in Chronic Urticaria
Study Start Date : June 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Urticarial Symptom Score [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Difference in Basophil Activation [ Time Frame: 10 weeks ]
  2. Difference in Rescue Medication Usage [ Time Frame: 10 weeks ]
  3. Difference in Dermatology Life Quality Index [ Time Frame: 10 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073852


Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Pogie Pongonis, MD Vanderbilt University
Study Director: John Fahrenholz, MD Vanderbilt University
More Information

Publications:
Responsible Party: John Michael Fahrenholz, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01073852     History of Changes
Other Study ID Numbers: Pending
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by John Michael Fahrenholz, Vanderbilt University:
Chronic Urticaria
Hives
Hydroxychloroquine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents