Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients

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 whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.


Eligibility Criteria:
Inclusion Criteria:

* 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 Criteria:

* 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.