Hydroxychloroquine Efficacy in Chronic Urticaria

Chronic Urticaria Clinical Trial

Official title:

Hydroxychloroquine Efficacy in Chronic Urticaria

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01073852
• Other study ID #: Pending
• Status: Withdrawn
• Phase: N/A
• First received: February 22, 2010
• Last updated: January 21, 2013
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

Drug:
• Placebo
Placebo pill, 1 pill orally twice daily for 9 weeks.
• Hydroxychloroquine
Patients will be taking hydroxychloroquine 200mg orally twice/daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urticarial Symptom Score		10 weeks	No
Secondary	Difference in Basophil Activation		10 weeks	No
Secondary	Difference in Rescue Medication Usage		10 weeks	No
Secondary	Difference in Dermatology Life Quality Index		10 weeks	No