study to determine the effect of an anti-ige agent on inflammatory cells in the skin of atopic dermatitis patients

Conditions: Atopic Dermatitis

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 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.

Keywords: serum ige levels inflammatory cells in the skin inflammatory cells in the blood ige ige depletion atopic dermatitis atopic eczema omalizumab