Clinical trial: A Multicenter Randomized Control Trial in Children With Moderate to Severe Atopic Dermatitis to Assess the Benefit of a Nurse-led One-to-one Education Program in Addition to Standard Care Compared to Standard Care Alone on the Long Term Control of Disease Severity at 6 Months (NCT02634905)

Eligibility criteria:
Inclusion Criteria:

          -  Patient with AD, defined according to the criteria of the United Kingdom Working Party
             : AD should be diagnosed when a child has an itchy skin condition plus three or more
             of the following: Protocol EDU DA RC15_0035 Version n°4 du 15/09/16 Page 28 sur 44
             CONFIDENTIAL Visible flexural dermatitis involving the skin creases, such as the bends
             of the elbows or behind the knees (or visible dermatitis on the cheeks and/or extensor
             areas in children aged under 10 years) Personal history of flexural dermatitis (or
             dermatitis on the cheeks and/or extensor areas in children under 10 years) Personal
             history of dry skin in the last 12 months Personal history of asthma or allergic
             rhinitis (or history of atopic disease in a firstdegree relative of children aged
             under 4 years)

          -  Onset of signs and symptoms under the age of 2 years (this criterion should not be
             used in children aged less than 4 years). Patient aged at least 3 months and less than
             18 years.

          -  SCORAD 20 (moderate to severe AD)

          -  Patient who received treatment an anti-inflammatory topical treatment (topical
             corticosteroid or topical tacrolimus)

          -  Informed consent of parents

          -  Agreement of the child when appropriate

          -  Patient affiliated to French social security system

        Exclusion Criteria:

          -  Patient does not meet the criteria of AD

          -  SCORAD < 20

          -  Patient aged 18 years or more

          -  Patient treated with oral corticosteroids currently or systemic immunosuppressant 2
             months prior to the eligibility assessment

          -  Patients with primary immunodeficiency diseases.

          -  Consent not given

          -  Patient not affiliated to French social security system

          -  Patient with intercurrent disease, may be excluded if the investigator believes
             participation in the trial is not in the best interest of the patient

          -  Personal decision of the child or their parents not to be included

          -  Child and / or parents lack the mental capacity to give informed consent

          -  Child / Parents do not have a sufficient command of the French language for
             understanding TPE program.

          -  Patient or parent who has already received structured TPE for AD.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 18 Years

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Entailment