Status:
COMPLETED
Efalizumab for Eczema
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00146003
Start Date
March 1 2005
End Date
December 1 2007
Last Update
August 7 2008
Active Locations (1)
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1
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903