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Efalizumab for Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226057
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : September 26, 2005
Information provided by:
Oregon Health and Science University

Brief Summary:
The purpose of this study is to determine if Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Raptiva Phase 1

Detailed Description:
Atopic dermatitis is a common, highly pruritic, inflammatory skin disease that affects up to 17% of school-aged children. Most cases of childhood atopic dermatitis improve or resolve by adulthood. However, the majority of patients retain some features of atopic dermatitis and some continue to have severe disease that continues to adulthood. Moderate to severe atopic dermatitis cannot be adeuately controlled with topical agents. Consequently many patients are treated with systemic corticosteroids, cyclosporine, azathioprine, methotrexate, and other immunosuppressants that carry the risk of severe atopic dermatitis is greatly needed. The chronic use of current immunosuppressive agents is limited by cumulative end-organ toxicities. We propose inhibition of T cell trafficking to the skin with Raptiva will have beneficial effects in the treatment of patients with moderate to severe atopic dermatitis.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efalizumab for Moderate to Severe Atopic Dermatitis - A Phase I Pilot Study in Adults
Study Start Date : June 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Primary Outcome Measures :
  1. The primary efficacy outcome measure will be the change in mean Eczema Area and Severity Index (EASI) score from baseline as measured at 12 weeks.

Secondary Outcome Measures :
  1. The following secondary efficacy outcome measures will be evaluated:
  2. Total percent of patients reaching 50% improvement in EASI score
  3. - Numbers of patient reaching clear, almost clear or mild disease on the Investigator Global Assessment (IGA) Score.
  4. - Subject's assessment of overall response
  5. - Change in serum IgE Level from baseline at 12 weeks
  6. - Pruritis (0-10 VAS Scale) change from baseline at 12 weeks.
  7. - Time to first response as defined by a decrease of 25% in EASI score on Days 28,56, and 84.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age >= 18 years
  • If a female of child bearing potential, a negative pregnancy test and commitment to birth control for the duration of the study are necessary.
  • Diagnosis of atopic dermatitis using the Hanifin-Rajka criteria
  • Disease severity of Moderate or Severe on the Rajka-Langeland Severity Score
  • Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, ultraviolet light or other immunosuppressant. Specifically, patients are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
  • Patients must meet the following washout requirements:

Pre-Study and Concomitant Washout Period Restriction (Baseline Therapy Restrictions Prior to Study Thru End of Study)

Investigational Drugs 4 Weeks Disallowed Light Treatments 4 Weeks Disallowed Systemic corticosteroid used 4 Weeks Disallowed for atopic dermatitis flare Topical tacrolimus or 2 Weeks Disallowed pimecrolimus Topical corticosteroids Must be on stable Allowed at stable doses dose for 2 weeks (Triamcinolone ointment 0.1% only) Any systemic 4 Weeks Disallowed immunosuppressive medication Topical and systemic antibiotics Cannot be on Allowed if infection antibiotics at the develops start of study

Exclusion Criteria:

  • Patient's with known hypersensitivity to Raptiva (efalizumab) or any of its components
  • Pregnant or lactating women
  • Patients receiving immunosuppressive agents
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial
  • Subjects known to be immunocompromised(lymphoma, HIV+, Wiskott-Aldrich syndrome)
  • Systemic corticosteroid-dependent asthma
  • Active infection of any type at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226057

Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Eric L Simpson, MD Oregon Health and Science University

Layout table for additonal information Identifier: NCT00226057     History of Changes
Other Study ID Numbers: 578
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: September 26, 2005
Last Verified: August 2005
Keywords provided by Oregon Health and Science University:
Atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases