COMFORT Toddlers Study

Please note: The COMFORT Toddlers Study is open to children 1-3 years old with a peanut allergy.

About the Study

Children’s National is looking for children to join the COMFORT Toddlers Study. This study is testing a skin patch treatment that may help retrain the immune system and lower the chance of an allergic reaction to peanuts.

Who can participate?

• Age: 1-3 years old
• Allergic to: Peanuts (or suspected of having a peanut allergy based on an evaluation from their doctor) 
• Diet: Strictly peanut-free
• Additional requirements: Access to emergency medicines (including epinephrine) and an up-to-date food allergy emergency action plan 

What is the COMFORT Toddlers Study?

The COMFORT Toddlers Study will gather additional information on a patch applied to your child's skin (study patch). It may help us to learn more about treating peanut allergy in toddlers in the future. 

Taking part in the study includes up to 14 visits to our office at Children’s National main campus, and 8 phone calls. The study lasts from 6–24 months (2 years) and includes a screening period of up to 6 weeks to see if your child is well matched to the study.  

Toddlers who qualify will be chosen at random (like flipping a coin) to wear either the study active patch or a placebo patch for the first 6 months in the study. The placebo patch looks the same but has no medicine. During the study you will apply a patch on your child’s back and change the patch every day and keep track of any skin reaction. Your child must stay on a peanut‑free diet during the entire study. 

After the first 6 months, you may choose to join an optional extension of the study, in which all participants will receive the active study patch for an additional 18 months. Two weeks after the last patch is used, you will have a follow-up phone call with the study team. 

A study of the efficacy of the peanut patch has already been completed in this age group, showing excellent results. This is an additional safety study.