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Atopic DermatitisPhase 4NCT00822783

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

A Phase 4 study testing Omalizumab in people with Atopic Dermatitis, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 60 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Omalizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteAustria
Study dates
Oct 2001to Apr 2003
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Division of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna, Austria.

    Vienna, Waehringer Guertel 18-20, 1090 Vienna

Other trials in Austria

About this study

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.

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.

Being tested
Omalizumab, Placebo
Keywords
Serum IgE levels, inflammatory cells in the skin, inflammatory cells in the blood, IgE, IgE depletion, atopic dermatitis, atopic eczema, Omalizumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabDrug

  • PlaceboDrug

Study groups in NCT00822783
Study groupRoleWhat they receive
OmalizumabActive comparatorNot described
Receives: Drug: Omalizumab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2009 (estimated)
  2. Study startOct 2001
  3. Study completionApr 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
IDs, dates and publications
ClinicalTrials.gov ID
NCT00822783
Sponsor's protocol ID
CIGE025A2412
Status last verified
Jan 2009
First submitted
13 Jan 2009
Last updated
14 Jan 2009
Results posted
No
Data monitoring committee
No

Publications

  • Lane JE, Cheyney JM, Lane TN, Kent DE, Cohen DJ. Treatment of recalcitrant atopic dermatitis with omalizumab. J Am Acad Dermatol. 2006 Jan;54(1):68-72. doi: 10.1016/j.jaad.2005.09.030. Epub 2005 Nov 28.

    PubMed 16384758

  • Krathen RA, Hsu S. Failure of omalizumab for treatment of severe adult atopic dermatitis. J Am Acad Dermatol. 2005 Aug;53(2):338-40. doi: 10.1016/j.jaad.2005.02.014.

    PubMed 16021135

  • Maurer D, Ebner C, Reininger B, Fiebiger E, Kraft D, Kinet JP, Stingl G. The high affinity IgE receptor (Fc epsilon RI) mediates IgE-dependent allergen presentation. J Immunol. 1995 Jun 15;154(12):6285-90.

    PubMed 7759866

  • Maurer D, Fiebiger E, Reininger B, Ebner C, Petzelbauer P, Shi GP, Chapman HA, Stingl G. Fc epsilon receptor I on dendritic cells delivers IgE-bound multivalent antigens into a cathepsin S-dependent pathway of MHC class II presentation. J Immunol. 1998 Sep 15;161(6):2731-9.

    PubMed 9743330

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omalizumab in people with Atopic Dermatitis, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00822783, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.

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