Clinical trial: Study of Skin Microbiome in Atopic Dermatitis Patients (NCT04170244)

Eligibility criteria:
Inclusion Criteria:

          -  ≥13 to 65 years of age (inclusive), male or female

          -  Able to understand protocol and give consent

          -  Able to keep clinic/study appointments and comply with study related procedures

          -  Must be able to read, speak, and understand English

          -  Chronic AD, according to the American Academy of Dermatology (AAD) Consensus Criteria,
             that has been present for at least 1 year before the enrollment visit

          -  Chronic PS, according to the AAD Consensus Criteria, that has been present for at
             least 1 year before the enrollment visit.

          -  AD subjects: have active lesions on upper extremities, lower extremities, or trunk and
             a total disease severity of high moderate-to-severe (EASI ≥12)

          -  PS subjects: have active lesions on upper extremities, lower extremities, or trunk and
             a total disease severity of high moderate-to-severe (PASI ≥7)

        Exclusion Criteria:

          -  Unwilling and/or unable to complete informed consent process

          -  <13 or > 65 years of age

          -  AD subjects: disease without upper extremity, lower extremity, or trunk lesions

          -  AD subjects: total disease severity less than moderate (EASI <12), depending on
             enrollment

          -  PS subjects: disease without upper extremity, lower extremity, or trunk lesions

          -  PS subjects: total disease severity less than moderate (PASI <7), depending on
             enrollment

          -  Control subjects: diagnosed with an inflammatory skin disease

          -  Severe concomitant illness(es) that, in the investigator's judgment, would adversely
             affect the individual's participation in the study (Ex: HIV infection, autoimmune
             disease, severe heart failure, Hx of malignancy (other than in situ cervical cancer or
             basosquamous skin cancer), etc.)

          -  Recent bacterial, fungal, or viral infection requiring systemic therapies (PO, IV or
             IM) within the last month.

          -  Patients with a history of keloid formation or lidocaine allergy may be enrolled but
             cannot undergo optional skin biopsies.

          -  Patients with a history of serious life-threatening reaction to tape or adhesives may
             be enrolled but cannot undergo optional TEWL measurements.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 65 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? Contradiction