Chronic Urticaria Clinical Trial
Official title:
Hydroxychloroquine Efficacy in Chronic Urticaria
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 |
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.
Status | Withdrawn |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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
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
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 |
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