A groundbreaking clinical trial is underway to test whether a nickel-sized device applied to the skin could help prevent dangerous peanut allergy reactions. Children's Healthcare of Atlanta has launched the first-in-human Phase 1 trial of a microneedle stamp developed by Atlanta-based Moonlight Therapeutics, Inc., which received FDA clearance to test the device in humans for the first time in late 2025.

How Does This Microneedle Stamp Work?

The microneedle stamp is a stainless steel device coated with small doses of peanut protein. Unlike traditional skin patch therapies where allergens sit on the surface, the microneedles penetrate slightly into the skin to deliver the protein more effectively. The stamp is applied to the forearm for about three minutes before removal, making it potentially less painful than an injection.

"The microneedle stamp is a stainless steel device the size of a nickel which is coated with small doses of peanut protein and designed to be applied to the skin of the forearm for about three minutes before removal. Since the microneedles only go slightly into the skin, the application may be less painful than an injection, and rather than the peanut proteins sitting on the outside like other skin patch therapies, we believe the stamp may be more effective at improving immune response to peanut allergy," said Brian Vickery, MD, Chief of Allergy and Immunology at Children's Healthcare of Atlanta.

Brian Vickery, MD, Chief of Allergy and Immunology at Children's Healthcare of Atlanta

Why Is This Treatment Needed?

Peanut allergy is one of the most common food allergies in the United States, affecting more than 1.2 million children. Approximately 30,000 children in the Atlanta metro area alone have a peanut allergy. The condition is serious because patients are at risk of anaphylactic reactions, which can occur from very small amounts of peanut exposure and may require emergency treatment with epinephrine auto-injectors if untreated.

Currently, only two therapies have received FDA approval for food allergies. One requires a subcutaneous injection of an antibody every two to four weeks, and the other, which was recently discontinued by the manufacturer, involves mixing powder into food daily. The microneedle approach offers a potentially more convenient alternative.

How Will the Trial Work?

The trial is being led by Children's Healthcare of Atlanta and Emory University, with four additional sites participating, including the University of North Carolina at Chapel Hill, the University of Arkansas, the University of Michigan, and a clinical research organization in Nebraska. The study will be conducted in three age-based cohorts:

• Initial Cohort: Young adults and adults aged 18 to 26 will be seen at Children's Healthcare of Atlanta, while adults aged 27 to 55 will participate at Emory University.
• Second Cohort: Following a safety review, younger teenagers will be enrolled if the stamp is determined to be safe in adults.
• Third Cohort: Children as young as four years of age could be enrolled following an adolescent safety review.

In the initial phase, researchers will start with one microgram of peanut protein and gradually increase the dose as tolerated. Participants will receive an active stamp on one forearm and a placebo on the other forearm each time the stamp is administered, initially applied once per week under supervision in the research clinic.

What Is the Goal of This Research?

The overall goal of the microneedle program is to determine whether repeated exposures through this therapy can alter the immune response to peanuts and create clinical desensitization. Researchers are testing whether the stamp can facilitate a new generation of advanced immunotherapy for food allergies.

"The microneedle approach may be a way to safely and precisely deliver, in just three minutes, a controlled dose of peanut protein to the immune system that could facilitate the next generation in advanced immunotherapy," explained Brian Vickery, MD.

Brian Vickery, MD, Chief of Allergy and Immunology at Children's Healthcare of Atlanta

The convenience factor was a key consideration in the device's design. Unlike current therapies that require frequent injections or daily ingestion of allergens, the microneedle stamp requires no eating or ingestion of peanuts and is designed for eventual home use.

The trial is funded by a National Institutes of Health U44 Small Business Innovation Research grant to Moonlight Therapeutics, Inc., with subcontracts to Emory University and Children's Healthcare of Atlanta. The microneedle technology builds on decades of research into vaccine delivery systems, with the founders of Moonlight Therapeutics having trained under Mark Prausnitz, PhD, a leading developer of microneedle technology at Georgia Tech.