Efalizumab for Eczema
This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey
First received: September 1, 2005
Last updated: August 6, 2008
Last verified: August 2008
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).
Drug: Efalizumab treatment
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Investigator-Initiated Trial of Efalizumab for Atopic Dermatitis: A Proof of Concept Study in Adults
Primary Outcome Measures:
- 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 Outcome Measures:
- 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)
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146003
|UMDNJ Psoriasis Center of Excellence
|New Brunswick, New Jersey, United States, 08903 |
University of Medicine and Dentistry of New Jersey
||Melissa Magliocco, MD
||Rutgers, The State University of New Jersey
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2005
||August 6, 2008
||United States: Institutional Review Board
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 03, 2015
Genetic Diseases, Inborn
Immune System Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic