Status:
COMPLETED
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Novartis
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesi...
Detailed Description
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the inna...
Eligibility Criteria
Inclusion
- Age 18-70 years
- Target lesion IGA ≥2
- Target IGA=0 (for non-lesional site)
- Male or female of any race and ethnicity
- Chronic AD for more than one year duration
- Subject of child-bearing potential must be willing to practice effective birth control during the study
- Subject agrees to comply with study requirements and attend all required visits.
Exclusion
- Patients ≥ 18 years of age with only AD of the face
- Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Hypersensitivity to pimecrolimus cream or any excipient of the cream
- Subject has a skin disorder in addition to dermatitis in the areas to be treated
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
- History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Patients known to be non-compliant with a medication regimen
- Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
- Active viral or fungal skin infections at the target areas
- Previous participation in this study
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
- Use of any local therapy for AD less than one week prior to screening
- Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00946478
Start Date
October 1 2009
End Date
May 1 2011
Last Update
March 10 2014
Active Locations (1)
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1
University of California, San Diego - Dept of Dermatology
La Jolla, California, United States, 92037