Clinical trial: Characterizing Skin Microbiome Change in Atopic Dermatitis (NCT04800185)

Eligibility criteria:
Inclusion Criteria:

          1. Patients aged 2 years or older at the time of consent.

          2. Patients may be male or female.

          3. Patients may have any skin phototype.

          4. Patients with a clinical diagnosis of atopic dermatitis according to the Hanifin and
             Rajka criteria. Atopic dermatitis diagnosis must be stable at least for 1 month per
             caregiver or patient.

          5. Atopic dermatitis affecting at least 5% of the patient's body surface area with at
             least two distinct lesional sites.

          6. Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's
             Static Global Assessment (iSGA).

          7. If greater than or equal to 18 years old at the time of consent, is able to provide
             written informed consent and will comply with all study procedures. If less than 18
             years old at the time of consent, parent or guardian is able to provide written
             informed consent with all children greater than or equal to 7 years old at the time of
             consent also providing written assent, and will comply with all study procedures.

        Exclusion Criteria:

          1. Patients less than 2 years old at the time of consent.

          2. Patients unable to provide written informed consent.

          3. Patients must not have used systemic biologic therapy, systemic immunosuppressive
             therapy, or systemic immunomodulating therapy within three months of baseline visit.

          4. Patients must not have had phototherapy within three months of baseline visit.

          5. Patients must not have used topical corticosteroids or topical calcineurin inhibitor
             within 28 days of baseline visit.

          6. Patients must not have previously been treated with topical phosphodiesterase-4
             inhibitor.

          7. Patients must not have a known hypersensitivity reaction to crisaborole or any of its
             known vehicle components.

          8. Patients must not have any active skin infection at the time of screening.

          9. Patients must not have any other overlying inflammatory disease such as psoriasis.

         10. Patients must not be currently pregnant, breastfeeding or planning pregnancy during
             the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.


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