Hydroxychloroquine Efficacy in Chronic Urticaria

This study has been withdrawn prior to enrollment.
(withdrawn, not funded)
Sponsor:
Information provided by (Responsible Party):
John Michael Fahrenholz, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01073852
First received: February 22, 2010
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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 Intervention
Chronic Urticaria
Drug: Placebo
Drug: Hydroxychloroquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Efficacy in Chronic Urticaria

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Urticarial Symptom Score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Basophil Activation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Difference in Rescue Medication Usage [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Difference in Dermatology Life Quality Index [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 22, 2010
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014