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 hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.
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 innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
University of California, San Diego - Dept of Dermatology
La Jolla, California, United States
Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD
Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo
Time frame: 3 weeks
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