Efalizumab for Eczema

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00146003
First received: September 1, 2005
Last updated: August 6, 2008
Last verified: August 2008

September 1, 2005
August 6, 2008
March 2005
Not Provided
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)
· Percent of subjects achievng "clear" to "almost clear" on the IGA. Success is achieved if 2 of 10 patients achieve clear or almost clear at any point in the study
Complete list of historical versions of study NCT00146003 on ClinicalTrials.gov Archive Site
  • 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)
  • · 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)
Not Provided
Not Provided
 
Efalizumab for Eczema
Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dermatitis, Atopic
Drug: Efalizumab treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2007
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00146003
5163
No
Not Provided
University of Medicine and Dentistry of New Jersey
Genentech, Inc.
Principal Investigator: Melissa Magliocco, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP