CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Viaskin Milk 500 mcg +1 moredrug
Likely dose
Viaskin Milk 500 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02579876
NCT02579876Phase 2Completed
CompareCT.gov

A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children

Children's Hospital of Philadelphia·interventional·Posted Oct 20, 2015·Updated Jul 10, 2019

In Brief

A Phase 2 clinical trial evaluating Viaskin Milk 500 mcg and Viaskin Placebo for Eosinophilic Esophagitis and Milk Allergy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis, Milk Allergy
CountriesUnited States
CollaboratorsDBV Technologies

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 20, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 20, 2017
Study CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.7 years ago

Interventions

Viaskin Milk 500 mcgdrug

Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.

Viaskin Placebodrug

Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.