At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled Randomized Trial to Study the Viaskin Milk Efficacy and Safety for Treating IgE-Mediated Cow's Milk Allergy in Children
In Brief
A Phase 2 clinical trial evaluating Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, and 2 other interventions for Food Allergy. Completed, enrolled 198 participants across 17 sites in 2 countries.
Detailed Summary
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.
Study Details
Timeline
Interventions
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.