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Urticaria clinical trials

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NCT ID: NCT01371877 Completed - Urticaria Clinical Trials

The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment

Start date: November 1, 2011
Phase: N/A
Study type: Interventional

This clinical study was designed based on our hypothesis that vitamin D plays an important role in chronic urticaria and that high dose supplementation with vitamin D in subjects with chronic urticaria will improve clinical response. This clinical study will investigate our hypothesis in three Specific Aims: 1. Determine whether high dosing vitamin D supplementation (4000 IU/day) reduces medication usage (primary outcome) and urticaria severity score (secondary outcome) in subjects with chronic urticaria as compared to low dosing (600 IU/day). 2. Determine if high dosing of vitamin D (4000 IU/day) is safe and well-tolerated in subjects with chronic urticaria with or without baseline vitamin D deficiency. 3. Investigate whether there is an association with serum 25-hydroxyvitamin D levels, vitamin D receptor mRNA expression, and chronic urticaria severity.

NCT ID: NCT01360658 Completed - Solar Urticaria Clinical Trials

Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

IGUS
Start date: June 2011
Phase: Phase 2
Study type: Interventional

Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.

NCT ID: NCT01292473 Completed - Clinical trials for Chronic Idiopathic Urticaria

A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

NCT ID: NCT01287117 Completed - Clinical trials for Chronic Idiopathic Urticaria

A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.

NCT ID: NCT01284426 Completed - Chronic Urticaria Clinical Trials

Natural History of Chronic Urticaria

NHCU
Start date: March 2003
Phase: N/A
Study type: Observational

The purpose of this study is to examine the natural history of chronic urticaria in children and to identify the predictors for chronic urticaria remission.

NCT ID: NCT01271075 Completed - Clinical trials for Cold Contact Urticaria

Bilastine Updosing - Characterization of Underlying Mechanisms

BUCUM
Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold contact urticaria (CCU). Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.

NCT ID: NCT01264939 Completed - Clinical trials for Chronic Idiopathic Urticaria

A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

Start date: February 2011
Phase: Phase 3
Study type: Interventional

The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

NCT ID: NCT01250652 Completed - Chronic Urticaria Clinical Trials

Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses

LevoHydroxy
Start date: March 2011
Phase: Phase 4
Study type: Interventional

Allen Kaplan is a prominent American allergist with the reputation of leader in the field of chronic urticaria. He advocates treatment with first generation hydroxyzine, which he considers at least as effective as modern second generation H1-blockers in suppressing the symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He further speculates that hydroxyzine may have the advantage to better suppress itch and improve nighttime sleep. This has prompted many practitioners around the world to believe that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to patients. At the same time European guidelines indicate modern second generation H1-blockers in higher than conventional doses as drugs of choice for such cases. However, there is no evidence from clinical trials addressing this controversy. The investigators' previous studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to treat urticaria by reducing lesions and itch, improving quality of life and night time sleep, while not causing day time somnolence. First generation H1-receptor antagonists and hydroxyzine among them are known to penetrate the blood / brain barrier and to cause sedation. The question stays whether this sedation is beneficial to the subjects with chronic urticaria at night, whether it has any hang-over unwanted effects the following day and whether this has any influence on the overall urticaria-specific quality of life.

NCT ID: NCT01170936 Completed - Vasculitis Clinical Trials

Ilaris® in Urticarial Vasculitis - Investigation of Treatment Responses

ILUVIT
Start date: July 2010
Phase: Phase 2
Study type: Interventional

This is a single-center open label study to assess the efficacy and safety of single doses of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with active urticarial vasculitis. Efficacy is primarily assessed by a combined symptom score, the urticarial vasculitis activity score (UVAS). Following a baseline period of 2 weeks, patients will be dosed with two single s.c. injections of 150 mg (consistent with a total dose of 300 mg canakinumab). Visits for investigator's assessments will be scheduled at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks post dose. Patient's self-assessment will be performed on a daily basis throughout the study. Overall a max. of 10 subjects with urticarial vasculitis will be enrolled.

NCT ID: NCT01111136 Completed - Chronic Urticaria Clinical Trials

Stress Intervention for Chronic Urticaria

Start date: March 2010
Phase: N/A
Study type: Interventional

Stress and chronic urticaria has been linked. The purpose of the study is to evaluate a patients chronic urticaria and stress levels before and after he/she goes through six sessions designed to help that participant manage his/her stress.