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High hopes surround dermatitis cream

Mayo among medical centers testing new treatment

By Jeff Hansel

jhansel@postbulletin.com

Baby William's skin was red, and he was getting bumps all over.

His mother, Melissa Schardt, tried everything. Fragrance-free laundry soap. Drying his skin really well after baths. Moisturizing cream.

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Then she learned about a study at Mayo Clinic.

A cream approved by the Food and Drug Administration was being tested against a placebo (the "normal" treatment) to see which worked better.

"I thought, 'If this would help, it's worth a shot,'" she said.

Mayo is one of several medical centers across the country participating in the study. Novartis Pharmaceutical Co. is sponsoring the Study Atopic March research trial. The cream is being used to treat atopic dermatitis, a condition that can make babies' skin break out in an uncomfortable rash that can lead to crankiness for babies -- and worry for parents.

"We're trying to find infants who are between the ages of 3 and 18 months," said Dr. Patricia Witman, a pediatric dermatologist at Mayo. Either a placebo or pimecrolimus cream (trade name Elidel) will be used. The theory, Witman said, is if the condition is controlled early, and inflammation is reduced, other allergic conditions might be delayed or reduced later on. Children with atopic dermatitis often later develop asthma and allergic diseases like hay fever, eczema and asthma. Atopic dermatitis is chronic and thought to be inherited, Witman said.

The goal in Rochester is to recruit 70 patients for the study, Witman said, with 1,400 nationally. For the first three years, half of the babies get pimecrolimus and the other half get a placebo, she said. The average age of onset for the dermatitis is 3 months, she said. The incidence of dermatitis in the United States has increased from one in 10 babies to about one in five. The condition can lead to infections, sleep disturbance, itching and problems at school.

"We don't know the cause, but what we suspect is happening is it has something to do with the immune system over-reacting to things in the environment," Witman said. Fragrances, cigarette smoke, wool or other environmental causes are all suspects.

"Kids will often outgrow it when they get older," she said.

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If the treatment for babies in either group is not working, they'll get the cortisone cream that's been the standard treatment for years, Witman said. After three years, all the babies will be put on pimecrolimus for the duration of the six-year trial, she said. To participate, babies must:

Be 3 to 18 months old.

Have atopic dermatitis.

Have one parent or sibling with a history of atopic dermatitis, allergies or asthma.

Schardt said her husband's family has a history of dermatitis. She said she talked with people who have eczema, which, Witman said, is often spoken of synonymously as dermatitis.

"They say it burns. It itches. It's really uncomfortable, and I thought, 'That's a terrible thing for a baby to have,'" she said. When William started the study, she said, "it just made a huge difference. His skin is clear." Before the treatment, "he wouldn't sleep for long periods and when he'd wake up, he'd be itching himself and squirming around."

But the cream he was assigned for the study seemed to work right away.

"The first week I noticed that his skin was getting better," Schardt said. "He didn't wake up grumpy and crying or itching." Although she's won't know until after the study which treatment William received, she likes it.

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"Once I put it on, his symptoms disappeared. I thought, 'Wow. This is wonderful,'" she said.

Participants are monitored by the Mayo dermatology department for six years and get free treatment. The condition usually worsens through the fall and winter months, so enrollment will continue through the end of December.

To register for or inquire about the study, call 284-9508.

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