Hydroxychloroquine Efficacy in Chronic Urticaria

• Sponsor: Vanderbilt University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01073852
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 12

Study Details

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	Phase
Chronic Urticaria	Drug: Placebo; Drug: Hydroxychloroquine	N/A

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
• 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: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

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 [10 weeks]

Secondary Outcome Measures

1. Difference in Basophil Activation [10 weeks]

2. Difference in Rescue Medication Usage [10 weeks]

3. Difference in Dermatology Life Quality Index [10 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Vanderbilt University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Reeves GE, Boyle MJ, Bonfield J, Dobson P, Loewenthal M. Impact of hydroxychloroquine therapy on chronic urticaria: chronic autoimmune urticaria study and evaluation. Intern Med J. 2004 Apr;34(4):182-6.

• Responsible Party: John Michael Fahrenholz, MD, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT01073852
• Other Study ID Numbers: Pending
• First Posted: Feb 23, 2010
• Last Update Posted: Jan 23, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by John Michael Fahrenholz, MD, Vanderbilt University: Chronic Urticaria; Hives; Hydroxychloroquine
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria; Hydroxychloroquine

Study Results

No Results Posted as of Jan 23, 2013