Cow’s Milk Allergy Treatment with Viaskin Milk Patch: The MILES Study – Phase I/II

Protocol Description

This multi-center research study is investigating the effectiveness and safety of the Viaskin® Milk, a patch for children with an allergy to cow’s milk, the most common food allergy in young children. Cow’s milk allergy (CMA) can persist during late childhood and through to adolescence. Allergic reactions after exposure/consumption of even small quantities of cow’s milk can be quite severe or even life threatening. Presently there is no treatment for CMA, other than avoidance, and accidental ingestion is a significant concern. The skin patch may reduce a child’s sensitivity to or enable tolerance of cow’s milk.

Study Level: Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, the study has accepted participants of both genders between the ages of 2 to 17 years who have a medical history or physician-confirmed diagnosis of IgE-mediated CMA with systemic symptoms related to ingestion of milk or dairy products
Males: 2 to 17 years old
Females: 2 to 17 years old

Requirements

Based on findings from the first year of the program, study participants will all use 300 micro-gram patches for a 2-year period, with visits scheduled at specific intervals.
Visits: Up to 8
Duration: About 3 years

Status: Closed to Enrollment

Source(s) of Support

DBV Technologies

Additional Information

Study Description from the National Institutes of Health

Primary Investigator

Hey Jin Chong, MD, PhD

Contact Information

For information about the study, please contact:
Linette Milkovich, RN
412-692-5383