Peanut and other nut allergies are a burden on families. But what if they could be treated with a simple skin patch? An ongoing clinical trial – funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, or NIAID – is investigating the effectiveness of a skin patch that uses epicutaneous immunotherapy, or EPIT, to potentially lessen the severity of reactions for those with the food allergy. The Viaskin patch is not yet approved by the Food and Drug Administration.
This immunotherapy method teaches “the immune system to tolerate enough peanut to protect against accidental ingestion or exposure,” NIAID’s director, Dr. Anthony S. Fauci, said in a statement. One-year results of the 2 1/2-year study were published Wednesday in the Journal of Allergy and Clinical Immunology.
The study, in which children ages 4 to 11 saw better results than those ages 12 and older, was conducted by the Consortium of Food Allergy Research, a group created to hold clinical trials, and perform observational studies and more related to food allergies.
Before the study began, researchers determined the participants’ degree of sensitivity to peanuts through a peanut-containing “food challenge.” “The test determines how much peanut protein can be eaten before an allergic reaction develops,” Dr. Marshall Plaut, co-author of the paper, tells U.S. News in an email. Study participants, totaling 74 people ages 4 and 25, each received patches containing a high dose of peanut protein, a low dose or a placebo with no traces of the allergen. Participants were instructed to put a new patch on their arm or between their shoulder blades every day. Patch side effects included itching or rashes, though there were no serious reactions reported.
One year later, researchers evaluated the participants’ tolerance for peanut protein – specifically, if they could have at least 10 times more than before the EPIT started (what the study defined as success, according to Plaut). Low-dose and high-dose treatment groups showed comparable results, with 46 percent and 48 percent respectively showing a boost in the ability to handle peanut protein. The placebo group, meanwhile, saw just a 12 percent bump.
Before the patch can gain widespread approval, larger studies must be done in children to further research the safety and effectiveness of the approach. For now, participants in the current study will all transition to using high-dose patches daily until the study ends.
Overall, food allergies impact approximately 4 to 6 percent of U.S. children, according to the Centers for Disease Control and Prevention.