The six-year prospective study, funded by Novartis, will be conducted in two stages. During the first three years a double blind study will compare the safety and effectiveness of pimecrolimus in conjunction with corticosteroid therapy for flare-ups, vs. corticosteroid therapy alone. Investigators hope that early treatment with pimecrolimus will reduce or prevent the need for corticosteroids. In the second three years, patients will be followed to see if they develop other allergic diseases, such as asthma, allergic rhinitis (hay fever), or allergic conjunctivitis (eye redness).
"The hope is that early and effective topical treatment of eczema in its early stages may help to prevent the later development of asthma, allergic rhinitis or allergic conjunctivitis," says Amy Paller, MD, lead site investigator and researcher at Children's Memorial Institute for Education and Research. Paller, head of dermatology at Children's Memorial, is professor of pediatrics and dermatology at Northwestern University's Feinberg School of Medicine.
"While eczema develops from birth to about three years of age in most affected children, other allergies such as asthma, begin in early childhood, and hay fever begins even later," she says. "We know that 50 to 80 percent of children who have eczema in infancy or childhood go on to develop asthma or other allergic diseases later on, especially if others in their immediate family have allergic disease. But we don't now why."
According to Paller, recent studies in mice have shown that when an allergenic substance, egg protein, was applied onto broken skin, the animals subsequently showed an allergic, asthma-like response in the lungs when exposed to the egg protein through lung inhalation. The lungs of mice whose skin had been exposed to salt water did not show an allergic response to the egg protein. This may indicate that allergenic substances that enter the bloodstream through untreated or poorly managed eczema can trigger later allergic responses, including asthma, hay fever and other conditions.
To be considered for the study, babies must have been diagnosed with eczema within the past three months, and have a parent or sibling with eczema, asthma, allergic rhinitis or allergic conjunctivitis.
Pimecrolimus has been tested for safety and effectiveness in hundreds of babies, and it is currently approved for use in eczema by the U.S. Food and Drug Administration for children as young as 2 years of age.
Children's Memorial Institute for Education and Research is the research arm of Children's Memorial Hospital and the center for pediatric research at Northwestern University. Children's Memorial Hospital is the pediatric teaching hospital for Northwestern University's Feinberg School of Medicine.