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Completed

NCT Number: NCT00146003

Efalizumab for Eczema

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Efalizumab treatment

Drug

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

  1. Percent of subjects achieving "mild," "almost clear," or "clear" on the IGA

  2. Percent improvement from baseline on the EASI (eczema area and severity index)

  3. Photography (quarter-body views, front and back)

  4. Pruritus improvement from baseline (rated on a scale of 1 to 10)

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults

Important dates

Study start
2005
Study completion
2007
First posted
Sep 5, 2005
Registry last updated
Aug 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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