Clinical trial: Systemic Therapies for Pediatric Atopic Dermatitis (NCT01447381)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of moderate, severe, or very severe atopic dermatitis meeting the Hanifin
             and Rajka criteria

          -  Needs systemic therapy (e.g. cyclosporine, azathioprine, mycophenolate mofetil, or
             methotrexate) for severe atopic dermatitis

          -  Subject has severe or recalcitrant disease interrupting daily life as evidenced by
             fulfilling 2 or more of the following 4 criteria:

               -  Failure of multimodal therapy including emollients/barrier repair, topical
                  anti-inflammatory agents (medium to high potency topical corticosteroids, and/or
                  low-potency or topical calcineurin inhibitors if facial/intertriginous areas),
                  and antihistamines

               -  Significant impairment in quality of life (physical, psychological, emotional)
                  such as significant sleep disruption, poor school performance, or frequent school
                  absenteeism, per the judgement of the investigator.

               -  Inability to receive, prior failure, or the need for more than one course of
                  phototherapy

               -  Prior failure or need for more than one course of another oral immunosuppressive
                  medication

          -  No serious medical condition that precludes the use of oral immunosuppressives based
             on the subject's medical history, physical examination, and safety laboratory tests.

          -  Negative PPD within the last year prior to study initiation.

          -  Female of childbearing potential has a negative pregnancy test at the time of starting
             the systemic drug and who consents to be abstinent or using an effective method of
             contraception during the study. Effective contraception is defined as IUD, condom with
             spermicide, diaphragm with spermicide, or stable use of a hormonal contraceptive
             (oral, implant, injection or transdermal patch) beginning at least 1 month prior to
             starting the systemic drug.

          -  Subject and parent/guardian are willing and able to comply with study instructions and
             return to the clinic for all required visits.

        Exclusion Criteria:

          -  Female who is pregnant, nursing, or planning a pregnancy during the study period.

          -  Concurrent participation in another clinical trial with an investigational drug or
             device that may impact on the individual's atopic dermatitis.

          -  Subjects with clinically significant hepatic disease, history of lymphoma or
             myelosuppression, low TMPT activity (if starting azathioprine), renal disease (if
             starting cyclosporine or azathioprine), hypertension (if starting cyclosporine), blood
             dyscrasias, or central nervous system disorders, such as uncontrolled seizures or
             peripheral neuropathy, or taking systemic medications that could interact adversely
             with the study medicine (e.g. erythromycin use with cyclosporine).

          -  Subjects with any underlying disease that the Investigator deems uncontrolled, and
             poses a concern for subject safety while participating on the study.

          -  Subject has a history of clinically significant drug or alcohol abuse in the last
             year.

          -  Subject is considered by the Investigator, for any reason, to be an unsuitable
             candidate for the study.

          -  Active systemic infection that could worsen with systemic therapy 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 2 Years old.
Subject must be at most 17 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? 1