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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00822783
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Omalizumab
Drug: Placebo
Phase 4

Study Type: Interventional
Official Title: An Exploratory 16 Week, Double Blind, Placebo-Controlled Single Center Mechanistic Study to Determine the Effect of Rhumab-E25 on Phenotype and Function of IgE Mediated Antigen Presentation by Dendritic Cells in Subjects With Atopic Dermatitis.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Study Start Date: October 2001
Estimated Study Completion Date: April 2003
Arms Assigned Interventions
Active Comparator: Omalizumab Drug: Omalizumab
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822783

Locations
Austria
Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.
Vienna, Waehringer Guertel 18-20, Austria, 1090 Vienna
Sponsors and Collaborators
Medical University of Vienna
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00822783     History of Changes
Other Study ID Numbers: CIGE025A2412
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Serum IgE levels
inflammatory cells in the skin
inflammatory cells in the blood
IgE
IgE depletion
atopic dermatitis
atopic eczema
Omalizumab

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 16, 2014