Conditions: Atopic Dermatitis
Keywords: atopic dermatitis elidel pimecrolimus CASM981 immunity cathelicidin antimicrobial peptide eczema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

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 hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.

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 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Pimecrolimus intervention 2: Vehicle cream
Intervention descriptions: intervention 1: 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). intervention 2: 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).

Protocol document: