Clinical trial: ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis (NCT03645057)

Eligibility criteria:
Inclusion Criteria:

        Pediatric Subjects:

          1. Male and female subjects of inclusive ages of 2 to 15 years (inclusive) at screening
             visit.

          2. Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥3% BSA, excluding
             scalp).

          3. If subject is taking or prescribed antihistamines, subject must be on stable dose of
             antihistamines.

          4. If subject is taking or prescribed topical steroids, subject must be on stable dose of
             topical steroids.

          5. If taking a systemic anti-inflammatory medication for atopic dermatitis or other
             condition, subject must be on stable dose of the systemic anti-inflammatory medication
             for six weeks prior to enrollment.

          6. If subject is currently taking or prescribed tacrolimus or crisaborole, or other
             steroid-sparring medication, subject must agree to two week (i.e., 14 days) washout
             period prior to randomization and Baseline Assessment for study.

          7. Caregiver (i.e., adult parent or guardian) must agree to participate in the study with
             the patient.

        e) Subject must be able to read and speak English. f) Subject ages ≥8 years, is able to
        give assent.

        Caregiver Subjects:

          1. Subject must be at least 18 years old and the parent or guardian of the eligible
             pediatric subject.

          2. Subject must be able to read and speak English.

          3. Subject must be able to give informed consent.

        Exclusion Criteria:

          1. Pediatric subjects <2 years old or >15 years old are not eligible for participation in
             this study.

          2. Pediatric subjects with a diagnosis with another skin disease (i.e., not atopic
             dermatitis or eczema) are excluded to prevent confounding of results.

          3. Pediatric subjects currently on systemic anti-inflammatory therapy for atopic
             dermatitis or other indication are excluded.

          4. Caregiver subject <18 years old are excluded.

          5. Pediatric subject participation without caregiver participation is not allowed.
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 15 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