Young Volunteers Needed For Stanford/Packard Study

Researchers at the Stanford University School of Medicine and 27 other institutions across the country are studying whether youngsters who receive prompt, consistent and long-term eczema treatment with a steroid-free cream will be less likely to develop the wheezing that signals the onset of asthma.

"The theory is that inflammation in the skin might make you more sensitive to inflammation in the lungs," said Alfred Lane, MD, professor of dermatology and of pediatrics and director of pediatric dermatology at Lucile Packard Children's Hospital.

There's some scientific evidence to support that idea. Mice primed for allergic skin reactions are also susceptible to an asthmatic lung reaction, Lane noted. But the question remains: if you block the rash, will you also block the wheeze?

In eczema, certain immune cells overreact to harmless substances that come in contact with the skin. Those are the same cells that overreact in the lungs of a person with asthma. "In both asthma and eczema the immune system is too excited, so the goal is to calm it down," Lane said.

Elidel, a steroid-free prescription cream containing pimecrolimus, prevents the excessive immune response that causes eczema, and researchers theorize that perhaps it can do the same for asthma.

To study whether the risk of getting asthma can be reduced in children whose eczema has been pacified at a very young age, the researchers are recruiting children between the ages of 3 months and 18 months who have eczema and whose mothers, fathers or siblings have eczema or asthma.

The volunteers' eczema must have been diagnosed in the previous three months. "We want them right when they first develop it," said Lane. "The idea is the earlier you can improve their skin, the better their outcome will be."

Study participants will be given either Elidel cream or a placebo cream to treat their eczema, and neither they nor their doctors will know which they are using. If the rash remains after a few days of treatment with the cream, all patients may then apply Cutivate, a cream containing a synthetic steroid that also relieves the skin condition.

"This is the standard treatment we would use for children with eczema," Lane said, "but it is a little more aggressive because we follow them more closely. And they get free medications-so they are more likely to use them."

In addition to six years of free medication, the volunteer's parents receive a Palm Pilot on which to record their child's skin condition and treatment.

Usually, Lane said, eczema gets better after 18 months of age, but asthma can develop years later. So the researchers will follow the volunteers for six years to see how many Elidel users start to wheeze compared with those treated only with Cutivate.

Sponsored by Novartis, the maker of Elidel, the study has an additional goal: to gain approval from the Food and Drug Administration to use Elidel in 3- to 18-month-old patients. The cream is already approved for use in patients ages 2 and up and is also routinely prescribed for younger children with eczema despite lacking FDA approval.

As in many clinical trials, Lane said, participants are doing better than patients who aren't part of the study. "The parents are motivated to give their kids better skin care," he explained. "They are applying moisturizers and medications and using the Palm Pilot, so most of the kids are doing really well."

Those interested in the study may call (650) 725-4302 or e-mail the study coordinator at DermStudies@yahoo.com. Information is also available at http://www.atopicmarchstudy.com.