In a “landmark” phase III trial, a skin patch to combat peanut allergies in children under the age of 4 has shown to be safe and more effective than placebo.

The patch works like exposure therapy, slowly training the toddlers’ bodies to tolerate proteins in peanuts that may cause an immune response in normal cases.

For 12 months, more than 300 children participated in the study. By the end of that period, 67% of the children didn’t experience adverse reactions to peanuts, double that of the placebo group.

The trial is considered the “gold standard,” which is to say it was double-blinded and placebo-controlled, meaning neither the kids nor the scientists knew who received the skin patch and who received the placebo patch.

The group that received the actual patch experienced more symptoms of peanut allergies during the 12 months of treatment—typical of exposure therapy—but side effects of the medicine itself were less than half of one percent.

“We were excited to contribute to this landmark study that carries so much promise for our young patients with peanut allergy,” said co-author Melanie Makhija, MD, who was the Principal Investigator of the study at Lurie Children’s Hospital.

“Children who originally reacted to a small fraction of a peanut were able to tolerate the equivalent of one to four peanuts after completing the treatment course. This means that these children will be well protected from accidental exposure to peanuts. Importantly, we found that the peanut patch was safe, with very low chances of a severe allergic reaction.”

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“This is terrific news for families of kids with peanut allergies,” she concluded.

Unlike allergies to shellfish or stonefruit, peanut allergies can be particularly dangerous because many facilities that jar and pack spices, grains, tree nuts, and other dry foodstuffs do so in the same facility as peanuts.

The trial, the results from which were published in the New England Journal of Medicine, is the first to demonstrate the safety and efficacy of a treatment for children under the age of 4.

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