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Hydroxychloroquine Efficacy in Chronic Urticaria

Hydroxychloroquine Efficacy in Chronic Urticaria

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01073852
Enrollment
0
Registered
2010-02-23
Start date
2011-06-30
Completion date
2012-06-30
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Urticaria

Keywords

Chronic Urticaria, Hives, Hydroxychloroquine

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.

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.

Interventions

DRUGPlacebo

Placebo pill, 1 pill orally twice daily for 9 weeks.

DRUGHydroxychloroquine

Patients will be taking hydroxychloroquine 200mg orally twice/daily.

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Urticarial Symptom Score10 weeks

Secondary

MeasureTime frame
Difference in Basophil Activation10 weeks
Difference in Rescue Medication Usage10 weeks
Difference in Dermatology Life Quality Index10 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026