Clinical trial: A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis (NCT03257644)

Eligibility criteria:
Inclusion Criteria:

          -  Pediatric subjects aged ≥ 2 to 17 years, inclusive

          -  Subjects diagnosed with AD as defined by the Hanifin and Rajka criteria.

          -  Subjects with active inflammation associated with AD.

          -  Subjects with an Investigator's Global Assessment (IGA) score of at least 2 at
             screening and baseline.

          -  Subjects with body surface area (BSA) of AD involvement of 8% to 20% at screening and
             baseline.

          -  Subjects who agree to discontinue all agents used to treat AD from screening through
             the final follow-up visit.

          -  Subjects of childbearing potential must agree to take appropriate precautions to avoid
             pregnancy or fathering a child for the duration of study participation.

          -  Written informed consent of the parent(s) or legal guardian and a verbal or written
             assent from the subject when possible.

        Exclusion Criteria:

          -  Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined
             by the investigator over the previous 4 weeks before baseline.

          -  Use of topical treatments for AD (other than bland moisturizer such as Eucerin® cream)
             within 2 weeks of baseline.

          -  Concurrent conditions and history of other diseases:

               -  Presence of AD lesions only on the hands or feet without a history of involvement
                  of other classical areas of involvement such as the face or the flexural folds.

               -  Other types of eczema.

               -  Any other concomitant skin disorder (eg, generalized erythroderma such as
                  Netherton Syndrome, or psoriasis), pigmentation, or extensive scarring that in
                  the opinion of the investigator may interfere with the evaluation of AD lesions
                  or compromise subject safety.

               -  Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome,
                  Wiskott-Aldrich syndrome) or have a history of malignant disease within 5 years
                  before the baseline visit.

               -  Chronic or acute infection requiring treatment with systemic antibiotics,
                  antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before
                  the baseline visit.

               -  Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster,
                  chicken pox) skin infection within 1 week before the baseline visit.

               -  Chronic asthma requiring more than 880 μg of inhaled budesonide or equivalent
                  high dose of other inhaled corticosteroids.

          -  Subjects with cytopenias at screening per protocol-defined criteria.

          -  Use of the following medications:

               -  Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable
                  corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine)
                  within 4 weeks or 5 half-lives of baseline (whichever is longer).

               -  Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole
                  within 2 weeks or 5 half lives, whichever is longer, before the baseline visit
                  (topical agents with limited systemic availability are permitted).

               -  Subjects who have previously received JAK inhibitors, systemic or topical (eg,
                  ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

               -  Current treatment or treatment within 30 days or 5 half-lives (whichever is
                  longer) before the baseline visit with another investigational medication or
                  current enrollment in another investigational drug protocol.

               -  Use of any prohibited medications within 14 days or 5 half-lives (whichever is
                  longer) of the baseline visit.

          -  Parent or legal guardian who, in the opinion of the investigator, is unable or
             unlikely to comply with the administration schedule and study evaluations or are
             unable or unwilling to apply the study drug.
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 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