<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223182</url>
  </required_header>
  <id_info>
    <org_study_id>MILES</org_study_id>
    <nct_id>NCT02223182</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy</brief_title>
  <acronym>MILES</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DBV Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DBV Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12&#xD;
      months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's&#xD;
      milk allergic children and to assess the long-term safety and therapeutic benefit with&#xD;
      Viaskin Milk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 22, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary efficacy endpoint will be the percentage (%) of subjects who are treatment responders after 12 months of EPIT treatment.</measure>
    <time_frame>From baseline to Month 12.</time_frame>
    <description>A treatment responder is defined as a subject who meets at least one of the following criteria:&#xD;
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins;&#xD;
A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean and median CRD of cow's milk proteins.</measure>
    <time_frame>From baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in levels of sIgE and sIgG4 to cow's milk.</measure>
    <time_frame>From baseline to Week 3, Month 3, Month 6, Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in levels of sIgE and sIgG4 to caseins, α-lactalbumin and β-lactoglobulin</measure>
    <time_frame>From baseline to Week 3, Month 3, Month 6, Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Skin Prick Test wheal.</measure>
    <time_frame>From baseline to Month 3, Month 6, Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the severity of symptoms elicited during the milk DBPCFC.</measure>
    <time_frame>From baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (QoL) assessments.</measure>
    <time_frame>From baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Up to 6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who are treatment responders over the course of the open-label treatment period.</measure>
    <time_frame>Up to 5 years in the open-label treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRD of cow's milk protein over the course of the open-label treatment period</measure>
    <time_frame>Up to 5 years in the open-label treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Food Allergy</condition>
  <arm_group>
    <arm_group_label>Viaskin Milk 150 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Milk 300 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Milk 500 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Milk 150 mcg</intervention_name>
    <description>Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.</description>
    <arm_group_label>Viaskin Milk 150 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Milk 300 mcg</intervention_name>
    <description>Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.</description>
    <arm_group_label>Viaskin Milk 300 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Milk 500 mcg</intervention_name>
    <description>Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.</description>
    <arm_group_label>Viaskin Milk 500 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Placebo</intervention_name>
    <description>Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.</description>
    <arm_group_label>Viaskin Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility criteria for study enrollment:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed&#xD;
             assent form (IAF) for subjects ≥7 years, or as per local or country specific&#xD;
             guidelines or regulations.&#xD;
&#xD;
          -  Male or female subjects 2 to 17 years old at Visit 1.&#xD;
&#xD;
          -  Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with&#xD;
             systemic symptoms related to ingestion of milk or dairy products.&#xD;
&#xD;
          -  Subjects currently following a strict cow's milk-free diet, with no consumption of&#xD;
             dairy or baked milk products.&#xD;
&#xD;
          -  Cow's milk-specific IgE level at screening ≥10 kU/L&#xD;
&#xD;
          -  Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm.&#xD;
&#xD;
          -  Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins&#xD;
             (approximately ≤9.4 mL of cow's milk).&#xD;
&#xD;
          -  Negative urine pregnancy test for female subjects of childbearing potential. Female&#xD;
             subjects of childbearing potential must agree and commit to use effective medical&#xD;
             methods of contraception for the entire duration of their participation in the study.&#xD;
             Sexual abstinence will be accepted as an effective method of contraception for girls&#xD;
             below 15 years of age.&#xD;
&#xD;
          -  Ability to perform spirometry procedures in accordance with the American Thoracic&#xD;
             Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak&#xD;
             expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects &lt;8 years of age&#xD;
             who have documented inability to adequately perform spirometry can perform only the&#xD;
             PEF evaluation. Subjects &lt;5 years of age may be enrolled if they had no clinical&#xD;
             features of moderate or severe persistent asthma severity (as defined by the 2007&#xD;
             National Heart, Lung, and Blood Institute [NHLBI] Guidelines) within 1 year before&#xD;
             Visit 1.&#xD;
&#xD;
          -  Subjects and/or parents/guardians willing to comply with all study requirements during&#xD;
             participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe anaphylaxis to cow's milk resulting in hypotension, hypoxia or&#xD;
             neurological compromise (collapse, loss of consciousness or incontinence) or requiring&#xD;
             mechanical ventilation.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Spirometry forced expiratory volume in 1 second (FEV1) &lt;80% of the predicted value at&#xD;
             Visit 1 for subjects ≥6 years and able to perform the spirometry, or PEF &lt;80% of&#xD;
             predicted value at Visit 1 for subjects performing only the PEF measurements.&#xD;
&#xD;
          -  Any clinical features of moderate or severe persistent asthma severity (as defined by&#xD;
             the 2007 NHLBI guidelines) and high daily doses of inhaled corticosteroids.&#xD;
&#xD;
          -  Known allergy to the Viaskin patch materials or excipients, or to any of the&#xD;
             components of the food challenge formulas other than the cow's milk proteins.&#xD;
&#xD;
          -  Allergy or known history of reaction to Tegaderm® medical dressing with no possibility&#xD;
             to use an alternative adhesive dressing authorized by the sponsor in replacement.&#xD;
&#xD;
          -  Subjects having objective symptoms to the placebo formula leading to stopping the&#xD;
             challenge during the screening DBPCFC.&#xD;
&#xD;
          -  Severe reaction during the screening DBPCFC defined as need for intubation, and/or&#xD;
             hypotension persisting after epinephrine administration, and/or the need for &gt;2 doses&#xD;
             of epinephrine.&#xD;
&#xD;
          -  Symptomatic allergy to pollens with symptoms during the pollen season that might&#xD;
             interfere with the symptoms observed during the DBPCFC, if the DBPCFC is performed&#xD;
             during the pollen season. Screening of such subjects should be made out of the pollen&#xD;
             season.&#xD;
&#xD;
          -  Inability to discontinue short-acting antihistamines for 3 days or long-acting&#xD;
             antihistamines for 5 to 7 days (depending on the half-life) before the DBPCFC.&#xD;
&#xD;
          -  Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 and/or use&#xD;
             of systemic short-acting corticosteroids within 4 weeks before Visit 1 or use of&#xD;
             systemic long-acting or short-acting corticosteroids during screening (unless used to&#xD;
             treat symptoms triggered by the DBPCFC or triggered by accidental allergen&#xD;
             consumption; in the latter case DBPCFC must then be scheduled after a minimum of 7&#xD;
             wash-out days).&#xD;
&#xD;
          -  Subjects with asthma conditions meeting 1 or several criteria below:&#xD;
&#xD;
               -  Uncontrolled persistent asthma (as defined by the 2007 NHLBI guidelines) or&#xD;
                  subject being treated with a combination therapy of medium or high daily dose of&#xD;
                  inhaled corticosteroid with a long acting inhaled β2-agonist. Intermittent&#xD;
                  asthmatic subjects who require intermittent use of inhaled corticosteroids for&#xD;
                  rescue are permitted.&#xD;
&#xD;
               -  At least 2 systemic corticosteroid courses for asthma within 1 year before Visit&#xD;
                  1 or 1 oral corticosteroid course for asthma within 3 months before Visit 1, or&#xD;
                  during screening (unless used to treat symptoms triggered by the DBPCFC).&#xD;
&#xD;
               -  Prior intubation/mechanical ventilation due to asthma within 2 years before Visit&#xD;
                  1, or during screening.&#xD;
&#xD;
          -  Upper respiratory infection or gastroenteritis within 7 days of DBPCFC (DBPCFC must&#xD;
             then be rescheduled at least 7 days after resolution of these conditions).&#xD;
&#xD;
          -  Any history of milk immunotherapy (eg, oral immunotherapy, sublingual immunotherapy or&#xD;
             specific oral tolerance induction).&#xD;
&#xD;
          -  Prior history of any other food allergen immunotherapy (eg, oral immunotherapy,&#xD;
             sublingual immunotherapy or specific oral tolerance induction) within 5 years before&#xD;
             Visit 1.&#xD;
&#xD;
          -  Subjects currently under aeroallergen immunotherapy and unwilling or unable to&#xD;
             discontinue at the time of Visit 1. Aeroallergen Immunotherapy must be discontinued at&#xD;
             the time of Visit 1.&#xD;
&#xD;
          -  Use of any anti-IgE drug (eg, omalizumab), any immunomodulatory therapy, or any&#xD;
             biological agent therapy (eg, anti-tumor necrosis factor drugs) within 1 year before&#xD;
             Visit 1, or during screening.&#xD;
&#xD;
          -  Generalized dermatologic diseases (eg, severe atopic dermatitis, uncontrolled&#xD;
             generalized eczema, icthyosis vulgaris) with no intact zones to apply the Viaskin&#xD;
             patch, or urticarial and mast cells disorders such as chronic idiopathic urticaria.&#xD;
&#xD;
          -  Subject and/or subject's parents/guardians with obvious excessive anxiety and unlikely&#xD;
             to cope with the conditions of a food challenge.&#xD;
&#xD;
          -  Past or current disease, including but not limited to active eosinophilic&#xD;
             gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy,&#xD;
             uncontrolled disease (hypertension, diabetes, psychiatric disorder, cardiac disease),&#xD;
             or other disorders (eg, liver, gastrointestinal, kidney, cardiovascular, pulmonary&#xD;
             disease or blood disorder) which in the opinion of the Investigator or the sponsor may&#xD;
             affect the subject's participation in the study or place the subject at increased&#xD;
             risk.&#xD;
&#xD;
          -  Subjects and/or parents/guardians unable to use the epinephrine auto-injector properly&#xD;
             in spite of being adequately trained.&#xD;
&#xD;
          -  Contraindicated condition for the use of epinephrine.&#xD;
&#xD;
          -  Use of any investigational drug or device, or participation in another interventional&#xD;
             clinical study within 3 months before Visit 1.&#xD;
&#xD;
          -  Subjects receiving beta-blockers or Angiotensin converting-enzyme (ACE) inhibitors.&#xD;
&#xD;
          -  Subjects unable to follow the protocol requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASTHMA, Inc.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheema Research Inc.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Allergy Research Corporation</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1G6C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4V 1R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Sainte Justine</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Spécialisée en allergie de la Capitale</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <disposition_first_submitted>July 31, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 31, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 8, 2019</disposition_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Milk Allergy,</keyword>
  <keyword>Viaskin Milk,</keyword>
  <keyword>Specific Immunotherapy,</keyword>
  <keyword>Epicutaneous ImmunoTherapy (EPIT)</keyword>
  <keyword>IgE-Mediated Cow's Milk Allergy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
    <mesh_term>Milk Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223182
org study id: MILES
nct id: NCT02223182
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary efficacy endpoint will be the percentage (%) of subjects who are treatment responders after 12 months of EPIT treatment.
time frame: From baseline to Month 12.
description: A treatment responder is defined as a subject who meets at least one of the following criteria:
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins;
A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
measure: Mean and median CRD of cow's milk proteins.
time frame: From baseline to Month 12
measure: Change in levels of sIgE and sIgG4 to cow's milk.
time frame: From baseline to Week 3, Month 3, Month 6, Month 12
measure: Change in levels of sIgE and sIgG4 to caseins, α-lactalbumin and β-lactoglobulin
time frame: From baseline to Week 3, Month 3, Month 6, Month 12
measure: Change in Skin Prick Test wheal.
time frame: From baseline to Month 3, Month 6, Month 12
measure: Change in the severity of symptoms elicited during the milk DBPCFC.
time frame: From baseline to Month 12
measure: Change in Quality of Life (QoL) assessments.
time frame: From baseline to Month 12
measure: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: Up to 6 years
measure: Percentage of subjects who are treatment responders over the course of the open-label treatment period.
time frame: Up to 5 years in the open-label treatment period
measure: CRD of cow's milk protein over the course of the open-label treatment period
time frame: Up to 5 years in the open-label treatment period
arm group label: Viaskin Milk 150 mcg
arm group type: Experimental
arm group label: Viaskin Milk 300 mcg
arm group type: Experimental
arm group label: Viaskin Milk 500 mcg
arm group type: Experimental
arm group label: Viaskin Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: Viaskin Milk 150 mcg
description: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
arm group label: Viaskin Milk 150 mcg
intervention type: Biological
intervention name: Viaskin Milk 300 mcg
description: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
arm group label: Viaskin Milk 300 mcg
intervention type: Biological
intervention name: Viaskin Milk 500 mcg
description: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
arm group label: Viaskin Milk 500 mcg
intervention type: Biological
intervention name: Viaskin Placebo
description: Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
arm group label: Viaskin Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
mesh term: Milk Hypersensitivity