Milk Patch for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis; Milk Allergy
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Milk Hypersensitivity
Intervention: Viaskin Milk 500 mcg; Viaskin Placebo
Intervention description: 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.; Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Milk Allergy; Viaskin Milk; Epicutaneous ImmunoTherapy (EPIT); Eosinophilic Esophagitis; Milk-Induced Eosinophilic Esophagitis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk
             and currently following a strict milk-free diet.

          -  Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing
             greater than 15 eosinophils/high power field (HPF) isolated to the esophagus meeting
             the consensus diagnosis of Eosinophilic Esophagitis, after milk was re-introduced into
             the subject's diet (30 ml/day for 1 week to 2 months), while the subject was on proton
             pump inhibitor.

          -  Upper endoscopy and biopsy at second clinical evaluation during Visit 3 showing less
             than 5 eosinophils per HPF isolated to the esophagus after a minimum of 6 weeks under
             milk-free diet, and while the subject is on proton pump inhibitor.

          -  Negative pregnancy test for female subjects of childbearing potential. Females of
             childbearing potential must use effective method of contraception to prevent pregnancy
             and agree to continue to practice an acceptable method of contraception for the
             duration of participation in the study. Sexual abstinence will be accepted as an
             effective method of contraception for girls below 18 years of age.

          -  Subjects and/or parents/guardians willing to comply with all study requirements during
             their participation in the study.

          -  Signed informed consent from parent(s)/guardian(s) of children < 18 years + children's
             assent.

          -  Subjects agree to maintain a constant diet during the trial, with the exception of
             milk.

          -  Subjects will maintain constant medications for asthma and allergic rhinitis during
             the trial.

        Exclusion Criteria:

          -  Subjects with a history of severe anaphylaxis to milk with the following symptoms:
             hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or
             incontinence), Quincke Edema or requiring intubation.

          -  Active IgE- mediated milk allergy.

          -  Pregnancy or lactation.

          -  Subjects with other eosinophilic gastrointestinal disorders.

          -  Subjects on swallowed corticosteroids or anti-leukotrienes for Eosinophilic
             Esophagitis.

          -  Subjects with symptomatic allergy to pollens whose symptoms during the corresponding
             pollen season might interfere with the recording of symptoms during the upper
             endoscopy/biopsy, if the upper endoscopy/biopsy is conducted during the pollen season.
             The Investigator will have to ensure that the period for conducting the upper
             endoscopy for such a subject will be outside of the pollen season.

          -  Subjects treated with systemic long-acting corticosteroids (depot corticosteroids)
             within 12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4
             weeks prior to Visit 1 or any systemic corticosteroid at screening.

          -  Subjects with asthma conditions defined as follows:

               1. Uncontrolled persistent asthma by National Asthma Education and Prevention
                  Program Asthma guidelines (2007).

               2. at least two systemic corticosteroid courses for asthma in the past year or one
                  oral corticosteroid course for asthma in the past three months;

               3. prior intubation for asthma in the past two years.

          -  Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin
             receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.

          -  Subjects undergoing any type of immunotherapy to any food within one year prior to
             Visit 1.

          -  Subjects presently on aeroallergen immunotherapy and unwilling or unable to
             discontinue.

          -  Subjects currently treated with anti-tumor necrosis factor drugs or
             anti-Immunoglobulin E (IgE) drugs or any biologic immunomodulatory therapy within one
             year prior to Visit 1.

          -  Allergy or known hypersensitivity to placebo excipients either of the Viaskin® or
             Tegaderm®.

          -  Subjects suffering from generalized dermatologic diseases with no intact skin zones to
             apply the Viaskin®, or urticarial and mast cell disorders such as chronic idiopathic
             urticaria.

          -  Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope
             with the conditions of an upper endoscopy and biopsy.

          -  Past or current disease(s), which in the opinion the sponsor-investigator, may affect
             the subject's participation in this study including but not limited to active
             autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases
             (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g.,
             liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood
             disorders).

          -  Any history of drug or alcohol abuse in the past five years.

          -  Subjects unable to follow the protocol and the protocol requirements.

          -  Participation in another clinical intervention study in the three months prior to
             Study Visit 1.

          -  Subjects on any experimental drugs or treatments.