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 Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.
In Brief
A Phase 2 clinical trial evaluating Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, and 2 other interventions for Peanut Allergy. Completed, enrolled 221 participants across 24 sites in 5 countries.
Detailed Summary
The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evaluate the safety of a long-term treatment with Viaskin Peanut.
Study Details
Timeline
Interventions
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation