Status:
COMPLETED
Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12-60 years
Phase:
PHASE4
Brief Summary
Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore wh...
Eligibility Criteria
Inclusion
- aged between 12 and 60 years
- clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)
- serum IgE between 30 and 1,300 IU/ml
- at least one significantly positive RAST
- a positive skin prick test of the same specificity as the RAST
- an Investigator's Global Assessment Score of 2 or more at randomization
- stable AD, as defined as active AD (IGA 2 or more) for \> 9 months per year
- signed informed consent.
Exclusion
- pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method
- treatment with omalizumab within the last 12 months before study treatment
- known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs
- elevated serum IgE levels for reasons other than atopy
- ongoing immunotherapy
- use of long-acting antihistamine astemizol within 3 months prior to visit1
- use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1
- use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1
- use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1
- use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication
- treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication
- use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)
- use of systemic antibiotics within 2 weeks prior to first application of study medication
- use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study
- immunocompromised patients or patients having a history of malignant disease
- concurrent skin diseases
- active bacterial, viral or fungal infections that required treatment with a prohibited medication
- a history of recurrent herpes simplex infection having active lesions at baseline
- tinea corporis / tinea cruris
- clinically significant laboratory abnormalities
- a history of noncompliance to medical regimens and patients who were considered potentially unreliable
- evidence of drug or alcohol abuse or other factors limiting ability to fully cooperate
- any condition or prior/continuing treatment which, in the opinion of the investigator, should have rendered the patient ineligible for the study.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00822783
Start Date
October 1 2001
End Date
April 1 2003
Last Update
January 14 2009
Active Locations (1)
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1
Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.
Vienna, Waehringer Guertel 18-20, Austria, 1090 Vienna