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Urticaria clinical trials

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NCT ID: NCT02285023 Completed - Chronic Urticaria Clinical Trials

The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire

CU-Q2oL
Start date: November 2014
Phase:
Study type: Observational

In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence. According to the International EAACI/GA2LEN/EDF/WAO Guidelines (the Dermatology Section of the European Academy of Allergology and Clinical Immunology(EAACI), the Global Allergy and Asthma European Network (GA2LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO) in Urticaria, using the Chronic Urticaria Quality of Life Questionnaire in a routine management is the key for a better treatment outcome. To translate this questionnaire into Thai is essential in our subject of interest in order to effectively apply it to local patients. The Thai-version questionnaire will encourage enhanced as well as impactful therapeutic options for Thai chronic urticaria patients.

NCT ID: NCT02262130 Completed - Solar Urticaria Clinical Trials

Omalizumab in Severe and Refractory Solar Urticaria

XOLUS
Start date: September 30, 2014
Phase: Phase 2
Study type: Interventional

Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.

NCT ID: NCT02238249 Completed - Urticaria Clinical Trials

Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria

Start date: October 2005
Phase: N/A
Study type: Observational

Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria

NCT ID: NCT02213367 Completed - Chronic Urticaria Clinical Trials

Bilastine Updosing in Chronic Spontaneous Urticaria

Start date: July 2014
Phase: Phase 3
Study type: Interventional

Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the population suffers from the disease. Although all age groups can be affected, the peak incidence is seen between 20 and 40 years of age. The duration of the disease is generally several years but is likely to be longer in more severe cases, cases with concurrent angioedema, in combination with physical urticaria or with a positive autologous serum skin test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep deprivation and psychiatric comorbidity being frequent. It also has a large impact on society in terms of direct and indirect health care costs as well as reduced performance at work and in private life.

NCT ID: NCT02171416 Completed - Clinical trials for Cold Contact Urticaria

Cold Contact Urticaria Treatment With Rilonacept

Cures
Start date: January 2015
Phase: Phase 2
Study type: Interventional

Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Typically, symptoms occur within minutes after cold contact, including exposure to cold air, liquids or objects and are limited to cold exposed skin areas. The investigators postulate that there is an overlap between acquired cold urticaria and cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to antihistamines will benefit from IL-1 targeting treatment strategies. This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept in patients with cold contact urticaria who could not be successfully treated with first-line medication such as antihistamines. This is a double-blind placebo-controlled parallel group phase II study of the efficacy and safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the Urticaria specialty clinics of ACC. The total duration of the study course for each patient is 14 weeks and is divided in: 1. Screening period (2 weeks, days -14-0) 2. Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42) 3. Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and will receive the respective dose subcutaneously. Following the placebo-controlled double-blind phase patients will enter the open-label phase and receive rilonacept open-label treatment (160mg or 320mg depending on treatment response during part A).

NCT ID: NCT02169115 Completed - Clinical trials for Symptomatic Dermographism

Urticaria Facticia Treatment With Omalizumab (UFO)

UFO
Start date: December 2012
Phase: Phase 2
Study type: Interventional

Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms, which either occur spontaneously, i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia (also known as dermographic urticaria and symptomatic dermographism) is characterized by whealing and itching following a minor stroking pressure, rubbing or scratching of the skin. The majority of patients with urticaria factitia benefits from treatment with nonsedating antihistamines. Some patients, however, do not achieve adequate symptom control even with updosing of antihistamines and may suffer from substantial quality of life impairment . Since even very minor stroking of the skin can lead to the development of wheals and severe itching, these patients are for example limited in their choice of clothing and are impaired in their social interaction and partnership. In all patients with a history of wheals after stroking of the skin, a provocation test should be performed. This can be done by stroking of the skin lightly with a smooth blunt object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the smooth blunt object should be held perpendicular to the skin and should be used to apply a light stroking pressure to the skin of the upper back or volar forearm. The reaction is considered positive in patients who show a weal response and report pruritus at the site of provocation. Patients with a positive test reaction should be evaluated for individual pressure thresholds. For this purpose a provocation device (FricTest) has been developed that allows for reproducible and standardized threshold testing. Threshold testing enables physicians to assess disease severity and treatment response more precisely.

NCT ID: NCT02161562 Completed - Clinical trials for Chronic Spontaneous Urticaria

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

OPTIMA
Start date: August 1, 2014
Phase: Phase 3
Study type: Interventional

This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab (150mg or 300mg). The study also assessed the benefit of uptitrating to 300mg dose in participants who were not well-controlled following their initial course of treatment with omalizumab 150mg, as well as the benefit of treatment extension of those patients who were not well-controlled following their initial course of treatment with omalizumab 300mg.

NCT ID: NCT02045524 Completed - Acute Urticaria Clinical Trials

A Pilot Single Dose Crossover Pharmacokinetics Study Of JDP-205 Injection, 10 mg, In Healthy Male And Female Volunteers

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The objective of this study was to investigate the pharmacokinetics (PK) of JDP-205 injection at 10 mg dose administered by intramuscular injection using various injection techniques in healthy male and female volunteers after a single dose administration.

NCT ID: NCT02024152 Completed - Acute Urticaria Clinical Trials

Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg

Start date: March 2011
Phase: Phase 1
Study type: Interventional

This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.

NCT ID: NCT02023164 Completed - Acute Urticaria Clinical Trials

Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria

Start date: July 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.