This study seeks to investigate the role of pimecrolimus in restoring disturbed skin barrier
function and reversing epidermal abnormalities found in atopic dermatitis (AD). The project
is based on findings the investigators presented at the recent SID meeting in Providence and
published in the J Invest Dermatol (122: 1423-31, 2004). The investigators research shows
that AD is characterized by impaired skin barrier function, reduced stratum corneum
hydration, impaired epidermal lipid composition and epidermal differentiation. In this
proposed project, the investigators wish to examine the influence of pimecrolimus and
betamethasone valerate on transepidermal water loss (TEWL) as a marker of the skin barrier
function, on stratum corneum hydration, on stratum corneum lipid content and on epidermal
differentiation regarding keratins and cornified envelope proteins in AD patients. The study
involves biophysical measurements of TEWL and skin hydration, lipid analysis,
immuno-histochemistry, Western blotting and micro array techniques. This study shall clarify
whether pimecrolimus restores the epidermal barrier and whether this contributes to the
beneficial effect of pimecrolimus on AD.
Objectives:
To explore the stratum corneum hydration, transepidermal water loss, capacity for barrier
repair and the integrity of the stratum corneum in patients treated with 1 % pimecrolimus
cream when applied twice a day to atopic dermatitis of the upper limbs, and to access the
substance's influences on the epidermis through histological, ultra-structural, and
biochemical analysis using punch biopsies from day 1 of one arm and day 22 from both treated
arms. 0.1 % betamethasone valerate cream b.i.d will be used as a control treatment.
Phase:
N/A
Details
Lead Sponsor:
University of Kiel
Collaborators:
Deutsche Forschungsgemeinschaft, Bonn, Germany Novartis Pharma GmbH, Nürnberg, Germany