Status:
COMPLETED
Efalizumab for Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Oregon Health and Science University
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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. How...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00226057
Start Date
June 1 2005
End Date
May 1 2006
Last Update
January 3 2020
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