Cow’s Milk Allergy Treatment with Viaskin Milk Patch – Phase I/II

Trial to Study the Efficacy and Safety of Viaskin Milk for Treating IgE-Mediated Cow’s Milk Allergy in Children

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 is accepting 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


Participants will be placed in groups that receive one of three dosages of Viaskin Milk or a placebo. Following a screening period of up to 2 months and requiring 3 visits, participants will use the patch for up to 2 years, with visits scheduled at specific intervals.
Visits: Up to 18
Duration: 27 months

Status: Open for Enrollment

Source(s) of Support

DBV Technologies

Primary Investigator

Todd Green, MD

Contact Information

For information about the study or enrollment, please contact:
Linette Milkovich, RN