"Researchers have long known that eczema and asthma are linked; however, there currently isn't an established, long-term treatment that controls eczema and thereby may have the ability to reduce the chances of developing asthma," said Jon Hanifin, M.D., professor of dermatology in the OHSU School of Medicine and principal investigator of the study.
Studies have shown that 50 percent of babies diagnosed with eczema at age 3 months who have a family history of allergic disease may develop asthma by age 5, according to Hanifin. He and his colleagues hope early intervention -- at ages 3 to 18 months -- and long-term treatment with the study drug Elidel will prevent the incidence of asthma in this highly susceptible patient population.
Last fall 17-month-old Elisabeth Haslam, Vancouver, Wash., developed a rash all over her legs and torso. "She itched terribly and scratched a lot," said Jennifer Haslam, Elisabeth's mother. After a month of incessant itching and scratching, Elizabeth's pediatrician recommended Jennifer enroll her daughter in Hanifin's study.
"I work in health care and know how difficult it can be to find patients willing to enroll in research studies," said Haslam. "My eldest daughter, Emily, who is now 5, also has eczema, mainly in the creases of her elbows, on the backs of her knees and the tops of her feet. She recently completed a separate clinical trial of Elidel at OHSU."
Eczema, also known as atopic dermatitis, is a chronic, recurring skin disease characterized by red, crusted lesions on the face, scalp and extremities, and by oozing, crusting, extremely itchy broken skin. Some 10 percent of infants develop eczema and it persists in roughly 15 million adults and children, according to a study conducted at OHSU in 2000.
For the first three years of the study, participants will receive standard therapy with moisturizers and steroid cream for flare-ups or the study drug with steroid cream rescue. During the final three-year phase of the study, all study participants will receive the study drug. At the end of the study period, researchers will determine whether early intervention with Elidel (at age 3 months) versus later intervention (3 years or older) decreases the incidence of asthma.
In large studies with kids aged 2 and older, Elidel proved more effective than regular maintenance with emollients in reducing the frequency of eczema flare-ups and reduced the need for steroids, according to Hanifin.
"Elidel appears to be safer than chronic steroid use and may lower the incidence of asthma," he said.
Eczema can develop at any age, but is most commonly diagnosed in infants, accounting for 60 percent of skin problems in children younger than 12, according to the American Academy of Dermatology. The exact of cause of eczema is unknown, but researchers have found that reactions to certain triggers -- changes in temperature, chemicals, scratchy fabrics, emotions or stress, and infections -- can cause children's immune systems to overreact and produce symptoms.
To participate in the study (IRB No. 7899), infants must be aged 3 to 18 months, have been diagnosed with eczema within the last three months, have no diagnosis of asthma, and have a parent or sibling with history of eczema, asthma or hayfever.
Some 200 infants will be enrolled in the six-year study. All study-related drugs and treatment (20 visits total) are provided at no charge.
The double-blind, multicenter, randomized study is funded by Novartis, however Hanifin and his colleagues are seeking additional funding from the National Institutes of Health to continue to follow children who do develop asthma during the study.
For more information about the study, call 503-228-7350. For more information about study volunteer opportunities at OHSU, visit www.ohsu.edu/research/rda/so/.