Efalizumab for Eczema - Full Text View

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	Genentech
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00146003

Purpose

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	Intervention	Phase
Dermatitis, Atopic	Drug: Efalizumab treatment	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Efalizumab

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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)

Estimated Enrollment:	10
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146003

Locations

United States, New Jersey
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Genentech

Investigators

Principal Investigator:

Melissa Magliocco, MD

University of Medicine and Dentistry New Jersey

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00146003 History of Changes
Other Study ID Numbers:	5163
Study First Received:	September 1, 2005
Last Updated:	August 6, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

eczema
atopic dermatitis
efalizumab

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012