Efalizumab for Eczema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Dermatitis, Atopic

Keywords

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eczema atopic dermatitis efalizumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Efalizumab treatment

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Melissa Magliocco, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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5163

Identifier Type: -

Identifier Source: org_study_id