Clinical trial: Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis (NCT01782703)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects may be of either sex and must be between the ages of 0 months and 17 years at
             the time of enrollment (Healthy controls, atopic controls, and AD patients)

          -  The skin sample and blood sample for healthy controls can have no systemic
             inflammatory disease or personal or familial history of atopy (hives, food allergy,
             allergic rhinitis or conjunctivitis, asthma)

          -  The atopic blood sample controls may have an atopic condition (allergic rhinitis or
             asthma) but no history of atopic dermatitis

          -  All controls for skin sampling may have no observable abnormality in the sampled skin
             and, to further assure the normality of the "normal" skin edges, must not have
             evidence of inflammation or epidermal change in the lesion to be surgically removed

          -  AD subjects must have mild to severe atopic dermatitis with either new onset disease
             within the last 6 months or with acute exacerbation of AD

          -  Subjects 17 years of age and older and parents/guardians of minors must sign the
             approved IRB assent and consent form(s) respectively prior to initiation of the study
             protocol

        Exclusion Criteria:

          -  Subjects unable to give assent or parents unable to give consent due to cognitive
             delay or inability to understand the assent form either in writing or presented
             verbally (Healthy controls, atopic controls, and AD patients)

          -  All subjects whose main diagnosis is deemed unsafe by the study investigator for study
             participation. Examples include known hemophilia or other blood disorders, or skin
             infection at the site of blood draw or biopsy (Healthy controls, atopic controls, and
             AD patients)

          -  Control subjects with obvious xerosis (Healthy controls and atopic controls)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers

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? Entailment