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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014