Patients with eczema will give themselves efalizumab injections weekly for 24 weeks. Their skin will be assessed on a monthly basis. There is no placebo in this study. Efalizumab is FDA-approved for psoriasis, another skin condition characterized by inflammation. The purpose of this study is to assess whether efalizumab is safe and effective for patients with eczema.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Efalizumab Administration	Phase II

Further Study Details: 

Primary Outcomes: · Percent of subjects achievng "clear" to "almost clear" on the IGA. Success is achieved if 2 of 10 patients achieve clear or almost clear at any point in the study
Secondary Outcomes: · 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)
Expected Total Enrollment:  10

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00146003

Irina Lipets, RN, BSN, CCRC      732-418-8474    lipetsir@umdnj.edu

New Jersey
      UMDNJ Clinical Research Center, New Brunswick,  New Jersey,  08903,  United States; Recruiting

Study chairs or principal investigators

Melissa Magliocco, MD,  Principal Investigator,  University of Medicine and Dentistry New Jersey   

Study ID Numbers:  5163
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00146003
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06