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ClinicalTrials.gov Identifier: NCT00146003
: September 5, 2005
Last Update Posted
: August 7, 2008
University of Medicine and Dentistry of New Jersey
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
Drug: Efalizumab treatment
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.
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
Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA
Percent improvement from baseline on the EASI (eczema area and severity index)
Photography (quarter-body views, front and back)
Pruritus improvement from baseline (rated on a scale of 1 to 10)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)