Efalizumab for Eczema

NCT00146003 | Completed Phase 2

• 1 other identifier: 5163
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Dermatitis, Atopic

Keywords

eczema; atopic dermatitis; efalizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Interventions

Efalizumab treatment DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Melissa Magliocco, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2005
• Study Completion: December 1, 2007
• Last Updated: August 7, 2008

Record last verified: 2008-08

Locations

US (1)