Clinical trial: Natural History of Diseases Associated With Allergic Inflammation: Atopic Dermatitis and Genetic and Congenital Diseases Associated With Atopic Pathways (NCT01164241)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. Subject or unaffected relatives must:

                    1. Be at least 2 years of age and less than or equal to 21 years of age at the
                       time of enrollment and have documented history of AD, by modified Hanifin
                       and Rajka criteria, that began in the first 5 years of life, that is
                       moderate to severe, and with continued active flares in the preceding 3
                       months. Patients greater than 21 years of age with active moderate to severe
                       AD may be enrolled, at the discretion of the PI or AIs, if they have a
                       history of AD in the first 5 years of life and/or, if in the opinion of the
                       PI or AIs, the patient would be of interest to fulfill the objectives of the
                       study.

                       OR

                    2. Be 2-80 years of age with a suspected genetic or congenital disorder
                       associated with atopy or affecting an atopic pathway, as determined by the
                       PI or AIs.

                       OR

                    3. Be an unaffected relative of a patient enrolled in the protocol.

               2. Have a private physician to provide local continuity of care.

               3. Provide a letter of referral, with copies of pertinent medical history and
                  laboratory studies as indicated, from prospective study participant s referring
                  physician; this is not a requirement for healthy relatives.

               4. Be willing to donate blood, buccal swabs, saliva, skin and nasal swabs for
                  research and clinical studies and for storage to be used for future research; for
                  unaffected relatives, be willing to donate blood and/or undergo allergy skin
                  testing, in addition to having blood samples stored for future research.

               5. Pregnant women or women who become pregnant are eligible to participate or
                  continue participation on the study.

        Healthy Volunteer must:

          1. Be at least 18 years old and no greater than 80 years old.

          2. Have no history of recent, active, moderate to severe atopic dermatitis.

          3. Be willing to have samples stored for research and genetic testing.

          4. For a subset of subjects participating in the cooling cuff procedure, be willing to
             have research skin biopsies performed.

        EXCLUSION CRITERIA:

        Any subject with any of the following criteria will be excluded:

          1. Presence of conditions that, in the judgment of the investigator or the referring
             physician, may put the subject at undue risk or make them unsuitable for participation
             in the study.

          2. Inability or refusal to undergo study procedures.

          3. Inability to participate for the duration of the study.

        Any unaffected relative or healthy volunteer with any of the following criteria will be
        excluded:

          1. Presence of conditions that, in the judgment of the investigator or the referring
             physician, may put the subject at undue risk or make them unsuitable for participation
             in the study.

          2. Inability or refusal to undergo study procedures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 80 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