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Efalizumab for Eczema

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ClinicalTrials.gov Identifier: NCT00146003
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 7, 2008
Genentech, Inc.
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:
The purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Efalizumab treatment Phase 2

Detailed Description:
The study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. Biologic plausibility rests on similarities in pathophysiology of the two conditions. The drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. The subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. Efalizumab is not being compared to placebo or other drugs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults
Study Start Date : March 2005
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Primary Outcome Measures :
  1. Percent of subjects achieving "clear" to "almost clear" on the Investigator Global Assessment [IGA] (success is achieved if 2 of 10 patients achieve "clear" or "almost clear" at any point in the study)

Secondary Outcome Measures :
  1. Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA
  2. Percent improvement from baseline on the EASI (eczema area and severity index)
  3. Photography (quarter-body views, front and back)
  4. Pruritus improvement from baseline (rated on a scale of 1 to 10)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement
  • Investigator Global Assessment (IGA) score of "moderate" or worse
  • In general good health with well-controlled medical problems
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
  • If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.
  • Normal platelet count

Exclusion Criteria:

  • Patients with known hypersensitivity to efalizumab or any of its components
  • Pregnancy or lactation
  • Patients receiving immunosuppressive agents
  • Prior enrollment in the study
  • Participation in another simultaneous medical investigation or trial
  • IGA score of "mild," "almost clear" or "clear"
  • Systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week
  • Medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy.
  • Ongoing, active, serious infection
  • History of malignancy (except excised basal or squamous cell carcinoma of the skin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146003

United States, New Jersey
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Genentech, Inc.
Principal Investigator: Melissa Magliocco, MD Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier: NCT00146003     History of Changes
Other Study ID Numbers: 5163
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: August 2008

Keywords provided by Rutgers, The State University of New Jersey:
atopic dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs