Dermatitis, Atopic
Conditions
Keywords
eczema, atopic dermatitis, efalizumab
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 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.
Interventions
DRUGEfalizumab treatment
Sponsors
Genentech, Inc.
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United States
Outcome results
None listed